|
3190
|
대한민국
|
생물학적제제 등의 품목허가·심사 규정(식품의약품안전처 고시 제2021-29호)
|
2021.04.09
|
|
|
3189
|
대한민국
|
「인체세포등 및 첨단바이오의약품의 허가 및 안전 등에 관한 규정」 일부개정고시(제2021-20호)
|
2021.03.23
|
|
|
3188
|
대한민국
|
「의약품 등의 안전에 관한 규칙」 일부개정령(총리령 제1683호, '21.3.8.)
|
2021.03.23
|
|
|
3187
|
대한민국
|
「의약품등 제조관리자 교육 및 교육실시기관 지정에 관한 규정」일부개정고시안 행정예고
|
2021.03.09
|
|
|
3186
|
대한민국
|
「의약품 임상시험 계획 승인에 관한 규정」 일부개정고시
|
2021.03.05
|
|
|
3185
|
대한민국
|
원료의약품 등록에 관한 규정
|
2021.02.24
|
|
|
3184
|
대한민국
|
식품의약품 등 위해소통민관협의회 운영규정 전문(국무총리훈령 제781호)
|
2021.02.08
|
|
|
3183
|
대한민국
|
디프테리아, 파상풍 및 정제백일해 기반 혼합백신 평가 가이드라인
|
2021.01.22
|
|
|
3182
|
대한민국
|
생물학적제제 등의 품목허가·심사 규정 일부개정고시안 행정예고 알림
|
2021.01.22
|
|
|
3181
|
대한민국
|
「의약품 병용금기 성분 등의 지정에 관한 규정」(식약처 고시 제2020-130호)
|
2021.01.08
|
|
|
3180
|
대한민국
|
「의약품등 생산 및 수출·수입 실적보고에 관한 규정」 (제2020-134호)
|
2021.01.08
|
|
|
3179
|
대한민국
|
「의약품 품목 갱신 업무 민원인을 위한 가이드라인」 개정
|
2020.12.23
|
|
|
3178
|
대한민국
|
「식품·의약품 등의 안전기술 연구개발사업 운영규정」 전부개정훈령(안) 행정예고
|
2020.12.22
|
|
|
3177
|
대한민국
|
「치료재료 급여·비급여 목록 및 급여 상한금액표」고시 일부 개정
|
2020.12.10
|
|
|
3176
|
대한민국
|
「건강보험 행위 급여·비급여 목록표 및 급여 상대가치점수」일부개정
|
2020.12.10
|
|
|
3175
|
대한민국
|
「의약외품 표시에 관한 규정」 전문
|
2020.12.10
|
|
|
3174
|
대한민국
|
식품의약품분야 시험검사 수수료에 관한 규정
|
2020.11.24
|
|
|
3173
|
대한민국
|
의약품 등의 안전에 관한 규칙 일부개정령(총리령 제1650호) 공포 알림
|
2020.11.06
|
|
|
3172
|
대한민국
|
「의약품 등의 허가 등에 관한 수수료 규정」 고시 전문
|
2020.10.21
|
|
|
3171
|
대한민국
|
융복합 혁신제품 지원단 운영세칙 및 신속 제품화 지원 등에 관한 규정 일부개정예규(안) 행정예고(제2020-444호)
|
2020.10.21
|
|
|
3170
|
대한민국
|
「신약 등의 재심사 기준」일부 개정고시(안) 행정예고
|
2020.10.07
|
|
|
3169
|
대한민국
|
「약사법」 일부개정법률안 입법예고
|
2020.10.07
|
|
|
3168
|
대한민국
|
「의약품동등성시험기준」 일부개정고시
|
2020.09.22
|
|
|
3167
|
대한민국
|
마약류 관리에 관한 법률 시행령
|
2020.09.22
|
|
|
3166
|
대한민국
|
의료법 시행규칙
|
2020.09.10
|
|
|
3165
|
대한민국
|
첨단재생의료 안전 및 지원에 관한 규칙
|
2020.09.10
|
|
|
3164
|
대한민국
|
첨단바이오의약품 안전 및 지원에 관한 규칙
|
2020.09.10
|
|
|
3163
|
대한민국
|
「약사법」 일부개정법률(안) 입법예고
|
2020.08.26
|
|
|
3162
|
대한민국
|
「첨단재생바이오법」시행령 국무회의 의결
|
2020.08.26
|
|
|
3161
|
대한민국
|
의약품 우수심사기준 업무수행편람(GRP-MaPP) 개정 보고(제5개정)
|
2020.08.11
|
|
|
3160
|
대한민국
|
의약외품에 관한 기준 및 시험방법 일부 개정 고시안 행정예고
|
2020.08.11
|
|
|
3159
|
대한민국
|
「의약품등의 해외제조소 등록에 관한 규정」 제정안 행정예고
|
2020.07.23
|
|
|
3158
|
대한민국
|
「의약품 병용금기 성분 등의 지정에 관한 규정」 일부개정고시
|
2020.07.23
|
|
|
3157
|
대한민국
|
「의약품등 제조관리자 교육 및 교육실시기관 지정에 관한 규정」 일부개정고시안 행정예고
|
2020.07.09
|
|
|
3156
|
대한민국
|
「첨단바이오의약품의 품목허가·심사 규정」 제정고시안 행정예고
|
2020.07.06
|
|
|
3155
|
대한민국
|
거짓.부정 의약품, 허가 취소 행정처분 기준 마련
|
2020.07.06
|
|
|
3154
|
미국
|
미국 FDA, 코로나19 치료제 및 바이오의약품 개발 관련 지침 발표
|
2020.06.30
|
|
|
3153
|
대한민국
|
「약제의 결정 및 조정기준」일부개정고시안 행정예고
|
2020.06.23
|
|
|
3152
|
대한민국
|
「대한민국약전」 일부개정고시(안) 행정예고
|
2020.06.10
|
|
|
3151
|
대한민국
|
마약류 관리에 관한 법률 시행령
|
2020.06.09
|
|
|
3150
|
대한민국
|
「감염병 예방 및 관리에 관한 법률」하위법령 공포
|
2020.06.09
|
|
|
3149
|
대한민국
|
시험검사 등 잔여검체 처리규정 일부개정예규
|
2020.05.27
|
|
|
3148
|
대한민국
|
「의약외품 범위 지정」 일부개정고시안 행정예고
|
2020.05.27
|
|
|
3147
|
대한민국
|
식품의약품안전처와 그 소속기관 직제 시행규칙
|
2020.05.27
|
|
|
3146
|
대한민국
|
중소기업기술개발 지원사업 기술료 관리규정
|
2020.05.12
|
|
|
3145
|
대한민국
|
의약품의 품목허가·신고·심사 규정 일부개정고시
|
2020.05.12
|
|
|
3144
|
대한민국
|
의약품 품목 허가사항 변경지시 알림[루트로핀알파 등 2개 성분]
|
2020.05.12
|
|
|
3143
|
대한민국
|
의약품 품목갱신 관련 알림(2021년 2분기 유효기간)
|
2020.04.24
|
|
|
3142
|
대한민국
|
임시마약류 지정 공고
|
2020.04.24
|
|
|
3141
|
대한민국
|
의약품 재심사 결과에 따른 허가사항 변경 지시 알림[타크로리무스수화물 제제(단일제, 경구제)]
|
2020.04.24
|
|
|
3140
|
대한민국
|
의약품 품목허가사항 변경지시 알림(메타콜린 성분제제)
|
2020.04.24
|
|
|
3139
|
대한민국
|
의약품 품목허가사항 변경지시 알림(히드록소코발라민 주사제)
|
2020.04.06
|
|
|
3138
|
대한민국
|
의약품 품목허가사항 변경지시 알림(페닐레프린 성분제제)
|
2020.04.06
|
|
|
3137
|
대한민국
|
약사법(2020. 3. 24. 타법개정)
|
2020.03.24
|
|
|
3136
|
대한민국
|
「의약외품 표시에 관한 규정」 고시 전문
|
2020.03.09
|
|
|
3135
|
대한민국
|
의약품 품목허가사항 변경지시 알림(미코페놀레이트 경구제)
|
2020.03.09
|
|
|
3134
|
대한민국
|
의약품 품목허가사항 변경지시 알림(펜토산폴리황산나트륨 성분제제)
|
2020.03.09
|
|
|
3133
|
대한민국
|
‘19년 12차「신의료기술의 안전성, 유효성 평가결과 고시」개정
|
2020.02.24
|
|
|
3132
|
헝가리
|
The application and verification of good laboratory practice
|
2020.02.21
|
|
|
3131
|
헝가리
|
On the administration and recording of fees payable in connection with certain authorization procedures for medicinal products for human use
|
2020.02.21
|
|
|
3130
|
헝가리
|
Test preparations for human use clinical trial and good clinical practice application
|
2020.02.21
|
|
|
3129
|
헝가리
|
Medicines for human use and others, amending the laws governing the pharmaceutical market
|
2020.02.20
|
|
|
3128
|
헝가리
|
Obligations concerning the reporting of post-authorisation adverse drug reactions in Hungary
|
2020.02.20
|
|
|
3127
|
헝가리
|
The pre-ion and dispensing of medicinal products for human use
|
2020.02.20
|
|
|
3126
|
헝가리
|
Authorizing the placing on the market and manufacture of medicinal products for human use
|
2020.02.20
|
|
|
3125
|
아일랜드
|
Renewal of Marketing Authorization - Human Medicines
|
2020.02.14
|
|
|
3124
|
아일랜드
|
The Notification System for Exempt Medicinal Products
|
2020.02.14
|
|
|
3123
|
아일랜드
|
Withdrawal of Authorisations of Certificates for Human Medicines
|
2020.02.14
|
|
|
3122
|
아일랜드
|
Definition of a Human Medicine
|
2020.02.14
|
|
|
3121
|
아일랜드
|
Reclassification(Switching) of Legal Supply Status for Human Medical Products
|
2020.02.14
|
|
|
3120
|
아일랜드
|
Medical Products(Control of Placing on the Market)(Amendment)Regulation 2019
|
2020.02.14
|
|
|
3119
|
터키
|
Non-Indication List of Drugs That Can Be Used Without TİTCK Supplementary Approval
|
2020.02.14
|
|
|
3118
|
터키
|
Hk Single or Combined Medicines Containing Acetyl Salicylic Acid.
|
2020.02.14
|
|
|
3117
|
터키
|
Medicines containing ranolazine (Latixa, Razina)
|
2020.02.14
|
|
|
3116
|
터키
|
Decree Law No. 663 on the Organization and Duties of the Ministry of Health and its Affiliates
|
2020.02.14
|
|
|
3115
|
터키
|
Convention on the Development of a European Pharmacopoeia
|
2020.02.14
|
|
|
3114
|
터키
|
1961 Single Convention on Drugs
|
2020.02.14
|
|
|
3113
|
터키
|
REGULATION ON PROMOTIONAL ACTIVITIES OF HUMAN MEDICAL PRODUCTS
|
2020.02.14
|
|
|
3112
|
터키
|
REGULATION ON THE AMENDMENT OF THE REGULATION ON THE PROMOTIONAL ACTIVITIES OF HUMAN MEDICAL PRODUCTS
|
2020.02.14
|
|
|
3111
|
터키
|
Law on the Execution of the Style of Tabet and Existence Art No. 1219
|
2020.02.14
|
|
|
3110
|
터키
|
The Pharmaceutical and Medical Preparations Law No. 1262
|
2020.02.14
|
|
|
3109
|
터키
|
Law on Pharmacists and Pharmacies No. 6197
|
2020.02.14
|
|
|
3108
|
터키
|
Law on Pharmacy Merchants and Shops Selling Toxic and Active Chemicals Used in Art and Agricultural Affairs
|
2020.02.14
|
|
|
3107
|
터키
|
Law on the Control of Narcotic Drugs No. 2313
|
2020.02.14
|
|
|
3106
|
터키
|
LAW ON PHARMACEUTICAL AND MEDICAL PREPARATION
|
2020.02.14
|
|
|
3105
|
터키
|
LAW ABOUT OPTICIAN
|
2020.02.14
|
|
|
3104
|
대한민국
|
약제 급여 목록 및 급여 상한금액표 고시 일부개정
|
2020.02.12
|
|
|
3103
|
대한민국
|
약사법 시행규칙(2020. 2. 7. 일부개정)
|
2020.02.11
|
|
|
3102
|
대한민국
|
4대 분야 15개 바이오헬스 핵심규제 개선
|
2020.01.21
|
|
|
3101
|
대한민국
|
특허침해 예방 이렇게 하세요
|
2020.01.21
|
|
|
3100
|
대한민국
|
｢R&D세액공제 사전심사｣ 제도
|
2020.01.20
|
|
|
3099
|
|
의약품 인허가 규제정보 현황(러시아, 카자흐스탄, 우즈베키스탄)
|
2020.01.08
|
|
|
3098
|
베트남
|
의약품 인허가 규제정보(한국,베트남 인허가 정책 비교 분석)
|
2020.01.08
|
|
|
3097
|
대한민국
|
희귀의약품 지정 공고
|
2020.01.07
|
|
|
3096
|
대한민국
|
「한약(생약)제제 등의 품목허가∙신고에 관한규정 」 일부개정고시(안) 행정예고 알림
|
2019.12.19
|
|
|
3095
|
대한민국
|
임시마약류 지정 공고
|
2019.12.18
|
|
|
3094
|
대한민국
|
국가필수의약품 지정 공고
|
2019.12.18
|
|
|
3093
|
대한민국
|
의약품 부작용 피해구제급여 지급 제외 대상 의약품 공고
|
2019.12.10
|
|
|
3092
|
대한민국
|
희귀의약품 지정 공고
|
2019.12.10
|
|
|
3091
|
대한민국
|
수입 인체조직 해외 제조원 등록 의무화
|
2019.12.05
|
|
|
3090
|
대한민국
|
의약품등 해외제조소, 12월 12일부터 등록 의무화
|
2019.12.05
|
|
|
3089
|
대한민국
|
약제 급여 목록 및 급여 상한금액표 일부개정 안내
|
2019.11.28
|
|
|
3088
|
대한민국
|
「의약품 병용금기 성분 등의 지정에 관한 규정」 일부개정고시(안) 행정예고
|
2019.11.14
|
|
|
3087
|
대한민국
|
의약품 품목 갱신에 관한 규정 일부개정고시(안) 행정예고
|
2019.11.08
|
|
|
3086
|
대한민국
|
「대한민국약전」 전부개정고시
|
2019.11.06
|
|
|
3085
|
대한민국
|
임시마약류 지정 예고
|
2019.10.24
|
|
|
3084
|
세르비아
|
세르비아에서 의약품 판매 라이센스를 취득하려면?
|
2019.10.22
|
|
|
3083
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(니페디핀 캡슐제)
|
2019.10.17
|
|
|
3082
|
중국
|
중국의 개정 <;;약품관리법>;; 중 신설 조항 전문
|
2019.10.14
|
|
|
3081
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(에녹사파린 성분제제)
|
2019.10.09
|
|
|
3080
|
아시아
|
해외 규제 정보 Update 제3호(2019년 9월)
|
2019.10.07
|
|
|
3079
|
유럽
|
유럽사법재판소, 의약품 임상시험 완료 전 상표 선점행위 관련 중요 판결 선고
|
2019.09.26
|
|
|
3078
|
중국
|
중국 의약품 규제 정보 알림
|
2019.09.19
|
|
|
3077
|
대한민국
|
의약품 허가사항 변경지시
|
2019.09.04
|
|
|
3076
|
대한민국
|
첨단재생바이오법 제정으로 달라지는 세가지
|
2019.08.29
|
|
|
3075
|
캐나다
|
캐나다 보건부, 특허의약품 규정 개정안 발표
|
2019.08.29
|
|
|
3074
|
터키
|
터키 지방법원, 의약품 인허가자료의 독점기간 만료 전 약식 허가신청 합법 판결
|
2019.08.29
|
|
|
3073
|
대한민국
|
클래리트로마이신 단일제(경구제) 허가사항 변경지시(통일조정) 사전예고
|
2019.08.27
|
|
|
3072
|
대한민국
|
아지트로마이신 단일제(경구, 주사제) 허가사항 변경지시(통일조정) 사전예고
|
2019.08.27
|
|
|
3071
|
대한민국
|
클린다마이신포스페이트 단일제(액제, 겔제) 허가사항 변경지시(통일조정) 사전예고
|
2019.08.27
|
|
|
3070
|
대한민국
|
생물학적동등성 인정품목 공고(2019년 7월)
|
2019.08.26
|
|
|
3069
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(엑세나타이드 성분제제)
|
2019.08.21
|
|
|
3068
|
대한민국
|
항생물질 주사제 허가사항 변경지시(통일조정)
|
2019.08.21
|
|
|
3067
|
대한민국
|
프로포폴 단일제(유화주사제) 허가사항 변경지시(통일조정) 사전예고 알림
|
2019.08.21
|
|
|
3066
|
|
의약품 허가사항 변경지시 사전예고
|
2019.08.21
|
|
|
3065
|
대한민국
|
알프라졸람 단일제(정제) 허가사항 변경지시(통일조정)를 위한 의견조회
|
2019.08.21
|
|
|
3064
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(실라자프릴 성분제제)
|
2019.08.13
|
|
|
3063
|
대한민국
|
의약품 품목허가사항 변경지시 관련 의견 제출 요청(세티리진/슈도에페드린 복합제)
|
2019.08.06
|
|
|
3062
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(렌바티닙 성분제제)
|
2019.08.06
|
|
|
3061
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(이반드론산나트륨일수화물 주사제)
|
2019.08.05
|
|
|
3060
|
대한민국
|
임시마약류 지정 공고
|
2019.07.29
|
|
|
3059
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(라듐-233염화물 성분제제)
|
2019.07.23
|
|
|
3058
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(프로톤펌프억제제)
|
2019.07.23
|
|
|
3057
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고(덱사메타손 성분제제)
|
2019.07.23
|
|
|
3056
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고(타크로리무스 성분제제)
|
2019.07.11
|
|
|
3055
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(테르비나핀염산염 성분제제)
|
2019.07.09
|
|
|
3054
|
대한민국
|
2019년도 2분기 의약품동등성시험 대조약 선정 및 변경 공고
|
2019.06.27
|
|
|
3053
|
대한민국
|
암환자에게 처방·투여하는 약제에 대한 공고 개정안내
|
2019.06.25
|
|
|
3052
|
대한민국
|
생물학적동등성 인정품목 공고(2019년 5월)
|
2019.06.25
|
|
|
3051
|
대한민국
|
의약품 적정사용을 위한 주의 정보의 공고
|
2019.06.21
|
|
|
3050
|
대한민국
|
2-플루오로펜타닐 등 3종 임시마약류 신규 지정 예고
|
2019.06.21
|
|
|
3049
|
대한민국
|
2019년도 2분기 대조약 선정 및 변경 의견조회(안)
|
2019.06.18
|
|
|
3048
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(아바나필 경구제)
|
2019.06.13
|
|
|
3047
|
대한민국
|
"의약품정보의 확인 및 정보시스템 운영 등에 관한 지침" 일부개정 알림
|
2019.06.12
|
|
|
3046
|
대한민국
|
의약품 품목허가사항 변경지시 사전예고 알림(프로필티오우라실 성분제제)
|
2019.06.10
|
|
|
3045
|
대한민국
|
암환자에게 처방•투여하는 약제에 대한 공고 개정 알림
|
2019.06.04
|
|
|
3044
|
대한민국
|
희귀의약품 지정 공고
|
2019.06.03
|
|
|
3043
|
캐나다
|
캐나다 보건부, 특허의약품 규정 개정안 발표
|
2019.05.30
|
|
|
3042
|
대한민국
|
2019년 의약품 소량포장단위 공급기준 차등적용품목 정정(추가) 공고
|
2019.05.29
|
|
|
3041
|
대한민국
|
「요양급여의 적용기준 및 방법에 관한 세부사항」일부개정
|
2019.05.29
|
|
|
3040
|
대한민국
|
「의약품 병용금기 성분 등의 지정에 관한 규정」 일부개정고시 알림
|
2019.05.29
|
|
|
3039
|
대한민국
|
「약제 급여 목록 및 급여 상한금액표」고시 일부개정
|
2019.05.28
|
|
|
3038
|
대한민국
|
임시마약류 지정 예고
|
2019.05.23
|
|
|
3037
|
대한민국
|
「한약재 안전 및 품질관리 규정」 일부개정고시(안) 행정예고
|
2019.05.20
|
|
|
3036
|
대한민국
|
의료용 마약류 불법사용 신속 대응체계 구축
|
2019.05.20
|
|
|
3035
|
대한민국
|
「의약품 제조 및 품질관리에 관한 규정」 일부개정고시(안) 행정예고 알림
|
2019.05.17
|
|
|
3034
|
대한민국
|
수입 원료의약품 품질검사 및 보관검체 보관 철저 안내
|
2019.05.17
|
|
|
3033
|
대한민국
|
의약품 품목허가사항 변경지시 알림(2019.5.13.)
|
2019.05.14
|
|
|
3032
|
대한민국
|
식품.의약품분야 시험.검사 등에 관한 법률 시행령 일부개정령 공포
|
2019.05.14
|
|
|
3031
|
대한민국
|
암환자에게 처방·투여하는 약제에 대한 공고 개정안내
|
2019.05.07
|
|
|
3030
|
대한민국
|
[약제]고시 제2019-88호 요양급여의 적용기준 및 방법에 관한 세부사항 안내
|
2019.05.07
|
|
|
3029
|
대한민국
|
의약품(발사르탄) 일부 품목 판매중지 등 조치해제
|
2019.05.02
|
|
|
3028
|
대한민국
|
「인체적용제품의 위해성평가 등에 관한 규정」
|
2019.04.22
|
|
|
3027
|
대한민국
|
「건강보험 행위 급여·비급여 목록표 및 급여 상대가치점수」일부개정
|
2019.04.15
|
|
|
3026
|
대한민국
|
「건강보험 행위 급여 비급여 목록 및 급여 상대가치점수」고시 일부 개정·발령
|
2019.04.09
|
|
|
3025
|
대한민국
|
임시마약류 지정 예고
|
2019.04.05
|
|
|
3024
|
대한민국
|
「연구소기업 등록절차 등에 관한 규정」 일부개정
|
2019.04.05
|
|
|
3023
|
대한민국
|
암환자에게 처방·투여하는 약제에 대한 공고 개정안내
|
2019.04.05
|
|
|
3022
|
대한민국
|
「요양급여의 적용기준 및 방법에 관한 세부사항」일부개정
|
2019.04.04
|
|
|
3021
|
대한민국
|
「요양급여비용 청구방법, 심사청구서·명세서서식 및 작성요령」일부개정
|
2019.04.04
|
|
|
3020
|
대한민국
|
고위험병원체 취급시설 및 안전관리에 관한 고시
|
2019.04.01
|
|
|
3019
|
대한민국
|
해외유입 기생충감염병 치료용 희귀의약품 관리규정(감염병 치료용 비축의약품 관리규정)
|
2019.04.01
|
|
|
3018
|
대한민국
|
허가초과 승인약제 사용 관련 질의응답
|
2019.03.29
|
|
|
3017
|
대한민국
|
의약품의 허가신고 갱신업무 가이드라인(민원인안내서)
|
2019.03.28
|
|
|
3016
|
미국
|
REMS Assessment: Planning and Reporting
|
2019.03.27
|
|
|
3015
|
미국
|
Nonproprietary Naming of Biological Products: Update
|
2019.03.27
|
|
|
3014
|
대한민국
|
대한민국약전(제2019-11호, 2019.2.28) 고시전문
|
2019.03.20
|
|
|
3013
|
대한민국
|
안전성유효성 문제성분 함유제제 공고
|
2019.03.20
|
|
|
3012
|
대한민국
|
수익자부담 해외출장여비에 관한규정
|
2019.03.19
|
|
|
3011
|
대한민국
|
「수입의약품등 관리 규정」
|
2019.03.19
|
|
|
3010
|
유럽
|
Draft ICH guideline M10 on bioanalytical method validation – step 2b
|
2019.03.14
|
|
|
3009
|
미국
|
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections; Guidance for Industry
|
2019.03.14
|
|
|
3008
|
미국
|
A Risk-Based Approach to Monitoring of Clinical Investigations; Questions and Answers; Guidance for Industry
|
2019.03.14
|
|
|
3007
|
미국
|
Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products; Guidance for Industry (Final)
|
2019.03.14
|
|
|
3006
|
대한민국
|
식품.의약품 등 연구개발 소식을 알려드립니다
|
2019.03.14
|
|
|
3005
|
미국
|
Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Draft Guidance for Industry
|
2019.03.12
|
|
|
3004
|
미국
|
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies; Guidance for Industry
|
2019.03.12
|
|
|
3003
|
미국
|
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients; Guidance for Industry
|
2019.03.12
|
|
|
3002
|
미국
|
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Guidance for Industry (Final)
|
2019.03.12
|
|
|
3001
|
대한민국
|
자가치료용 대마성분 의약품 취급승인 및 수입 신청 안내서
|
2019.03.05
|
|
|
3000
|
대한민국
|
「대한민국약전」 일부개정고시
|
2019.03.04
|
|
|
2999
|
대한민국
|
의약품 등의 제조업 및 수입자의 시설기준령 시행규칙 일부개정령(안) 입법예고
|
2019.02.27
|
|
|
2998
|
대한민국
|
「식품·의약품 등의 안전기술 진흥법」시행령 및 시행규칙 일부개정안 입법예고
|
2019.02.27
|
|
|
2997
|
대한민국
|
「의약품 등의 안전에 관한 규칙」 일부개정령 공포(제1521호, 2019.2.11)
|
2019.02.27
|
|
|
2996
|
미국
|
Rare Diseases: Common Issues in Drug Development (Draft)
|
2019.02.25
|
|
|
2995
|
대한민국
|
의약품 광고 및 전문의약품 정보제공 가이드라인(민원인 안내서) 개정 알림
|
2019.02.25
|
|
|
2994
|
유럽연합
|
[국외 GMP 관련 규정] PIC/S 가이드라인(PI-040-1, CLASSIFICATION OF GMP DEFICIENCIES)
|
2019.02.25
|
|
|
2993
|
대한민국
|
「연구소기업 등록절차 등에 관한 규정」개정(안)
|
2019.02.25
|
|
|
2992
|
미국
|
Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research(CBER) in Electronic Format
|
2019.02.22
|
|
|
2991
|
대한민국
|
약사법 시행령 및 의약품 등의 안전에 관한 규칙 일부개정령(안) 입법예고 알림
|
2019.02.22
|
|
|
2990
|
대한민국
|
의약품 해외제조소 등록 및 현지실사 시행규정 마련
|
2019.02.22
|
|
|
2989
|
유럽
|
Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials
|
2019.02.21
|
|
|
2988
|
미국
|
Labeling of Red Blood Cell Units with Historical Antigen Typing Results
|
2019.02.20
|
|
|
2987
|
대한민국
|
「대한민국약전외한약(생약)규격집」일부개정고시
|
2019.02.20
|
|
|
2986
|
대한민국
|
「수입요건확인 면제대상 물품 중 의약품등의 추천요령」
|
2019.02.19
|
|
|
2985
|
미국
|
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies
|
2019.02.15
|
|
|
2984
|
미국
|
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
|
2019.02.15
|
|
|
2983
|
대한민국
|
의약품 GMP 영문증명 개선 알림
|
2019.02.15
|
|
|
2982
|
대한민국
|
'원료의약품 행정처분 정보 EU 통보 지침(공무원지침서)' 제정 알림
|
2019.02.12
|
|
|
2981
|
미국
|
Principles of Premarket Pathways for Combination Products
|
2019.02.06
|
|
|
2980
|
대한민국
|
원자재업체 관리(Vendor Audit) 방안 안내(민원인 안내서) 개정 알림
|
2019.02.01
|
|
|
2979
|
유럽
|
Electronic product information for human medicines in the EU - draft key principles
|
2019.01.31
|
|
|
2978
|
미국
|
Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
|
2019.01.29
|
|
|
2977
|
독일
|
BfArM FAQs: Clinical Trials - Clinical Issues
|
2019.01.28
|
|
|
2976
|
브라질
|
ANVISA Information Note: Inquires During the Review Process of Medidinal Products Applications to be Answered via Electronic Submission System
|
2019.01.25
|
|
|
2975
|
독일
|
BfArM Form: Application Observation (AWB) According to §67 Paragraph 6 of the German Medicines Act (AMG)
|
2019.01.25
|
|
|
2974
|
독일
|
BfArM Information Note: Reporting Post-authorization Safety Assessments (PASS)
|
2019.01.25
|
|
|
2973
|
미국
|
Immunogenicity Testing of Therapeutic Protein Products - Developing and Validating Assays for Anti-Drug Antibody Detection
|
2019.01.23
|
|
|
2972
|
미국
|
Labeling for Human Pre-ion Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway
|
2019.01.22
|
|
|
2971
|
독일
|
BfArM FAQs: On Renewals
|
2019.01.22
|
|
|
2970
|
독일
|
BfArM Information Note: Clinical trials with Medicinal Products with a Sponsor based in the United Kingdom
|
2019.01.18
|
|
|
2969
|
독일
|
Federal Joint Committee (G-BA) Guidance: Rules of Procedure of 18-Dec-2008
|
2019.01.17
|
|
|
2968
|
독일
|
Federal Joint Committee (G-BA): Consultation Application Form
|
2019.01.17
|
|
|
2967
|
대한민국
|
「의약품 임상시험 등 종사자 교육 및 교육실시기관 지정에 관한 규정
|
2019.01.17
|
|
|
2966
|
아르헨티나
|
Official Notice: Authorization for the Import/Export of Biological Samples Linked to Clinical Trials
|
2019.01.16
|
|
|
2965
|
아르헨티나
|
Disposition 513/2019: Marketing Authorization Applications Requirements for Synthetic and/or Semi-Synthetic Medicinal Products with APIs that do not Require Bioequivalence and/or Biodisponibility Demonstration
|
2019.01.15
|
|
|
2964
|
독일
|
PEI: List of Compassionate Use Programms of the Paul-Ehrlich Institut
|
2019.01.15
|
|
|
2963
|
독일
|
Federal Ministry of Health: Registry of Brokers of Medicinal Products
|
2019.01.14
|
|
|
2962
|
아르헨티나
|
Circular 002/2019: Suspension of Procedures due to Bioequivalence Non-Compliance
|
2019.01.10
|
|
|
2961
|
아르헨티나
|
Circular 001/2019: Extension of Bioequivalence Studies Results
|
2019.01.10
|
|
|
2960
|
아르헨티나
|
Disposition 271/2019: Creates the Comprehensive Program of Biodisponibility, Bioequivalence and Interchangeability of Medicinal Products
|
2019.01.10
|
|
|
2959
|
독일
|
PEI: Information on Handling of Fees for Clinical Trials
|
2019.01.08
|
|
|
2958
|
아르헨티나
|
List of CODES: Fees to be paid to ANMAT for Procedures Related to Medicinal Products
|
2019.01.03
|
|
|
2957
|
독일
|
G-BA Information Note: The Benefit Assessment of Pharmaceuticals in Accordance with the German Social Code, Book Five (SGB V), Section 35a
|
2019.01.03
|
|
|
2956
|
독일
|
BfArM FAQs: on Preparation, Submission and Implementation of Educational Materials
|
2019.01.03
|
|
|
2955
|
독일
|
BfArM: List of Published Summaries of Risk Management Plans
|
2018.12.31
|
|
|
2954
|
대한민국
|
[생물의약품] 동등생물의약품 허가 및 심사를 위한 질의응답집(개정)
|
2018.12.31
|
|
|
2953
|
아르헨티나
|
Disposition 3049/2018: Updates the Fees for Administrative Procedures Related to Medicinal Products
|
2018.12.27
|
|
|
2952
|
대한민국
|
[생물의약품] 18년 제2차 바이오의약품 허가심사 설명회(Bio-Update) 발표자료
|
2018.12.26
|
|
|
2951
|
브라질
|
Public Consultation 587: Import/Export of Substances, Plants and Medicinal Products Subjected to Special Control (Draft)
|
2018.12.24
|
|
|
2950
|
미국
|
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
|
2018.12.24
|
|
|
2949
|
브라질
|
Resolution RDC 260: Regulations of Clinical Trials with Advance Therapy Investigational Medicinal Products
|
2018.12.21
|
|
|
2948
|
미국
|
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
|
2018.12.21
|
|
|
2947
|
독일
|
BfArM and PEI: Pharmacovigilance Bulletin, 4rd Issue
|
2018.12.20
|
|
|
2946
|
독일
|
PEI Information Note: Current Information on the Notification According to § 21 of the Law to Regulate Transfusion Products (TFG)
|
2018.12.20
|
|
|
2945
|
독일
|
PEI: Glossary for Reporting According to § 21 of the Law to Regulate Transfusion Products (TFG)
|
2018.12.20
|
|
|
2944
|
독일
|
BfArM: Information Note on Electronic Submission (eSubmission)
|
2018.12.20
|
|
|
2943
|
브라질
|
Resolution RDC 207: Requirements for the Organization of the Sanitary Surveillance Actions, 03-Jan-2018
|
2018.12.19
|
|
|
2942
|
독일
|
BMG Announcement of 17-Jun-2016: Import of Medicinal Products upon Entry into Germany
|
2018.12.19
|
|
|
2941
|
독일
|
BfArM Information Note: Consequences of Brexit for Future and Ongoing Clinical Trials
|
2018.12.18
|
|
|
2940
|
브라질
|
Resolution RDC 10: Sets forth Provisions on the Quality of Imported Medicinal Products, 21-Mar-2011
|
2018.12.18
|
|
|
2939
|
독일
|
Law of 24-Jul-1972: Animal Protection
|
2018.12.17
|
|
|
2938
|
독일
|
BfArM Information Note: Joint Pilot Project between Federal Higher Authorities and Ethics Committees for Processing Applications for the Authorization of Clinical Trials on Medicinal Products according to Regulation (EU) No 536/2014
|
2018.12.17
|
|
|
2937
|
독일
|
Federal Joint Committee (G-BA) Guidance: Rules of Procedure of 18-Dec-2008
|
2018.12.17
|
|
|
2936
|
브라질
|
Resolution RDC 255: Approves the Internal Regimen of ANVISA
|
2018.12.17
|
|
|
2935
|
독일
|
Administrative Instruction of 29-Mar-2006 for the Enforcement of the Drug Law (AMGVwV)
|
2018.12.17
|
|
|
2934
|
독일
|
Paul Ehrlich Institute Presentation: Organization Chart
|
2018.12.15
|
|
|
2933
|
미국
|
Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry
|
2018.12.14
|
|
|
2932
|
독일
|
PEI: Glossary of the Registration Form According to §8d Abs.3 of the Law on Transfusion (TPG) for the reporting year 2018
|
2018.12.14
|
|
|
2931
|
독일
|
PEI Information Note: Legal Basis for the Reporting Obligation of Tissue Facilities According to the §8d Abs.3 of the Law on Transfusion (TPG)
|
2018.12.14
|
|
|
2930
|
미국
|
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers
|
2018.12.13
|
|
|
2929
|
미국
|
Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009
|
2018.12.13
|
|
|
2928
|
미국
|
Biomarker Qualification: Evidentiary Framework
|
2018.12.13
|
|
|
2927
|
미국
|
Questions and Answers on Biosimilar Development and the BPCI Act
|
2018.12.13
|
|
|
2926
|
미국
|
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)
|
2018.12.13
|
|
|
2925
|
독일
|
BfArM: Structure of the Federal Institute for Drugs And Medical Devices (BfArM), Organization Chart
|
2018.12.12
|
|
|
2924
|
브라질
|
Order 1.741: Sets out Requirements and Procedures for the Improvement of the Regulatory Quality within Anvisa
|
2018.12.12
|
|
|
2923
|
미국
|
Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
|
2018.12.12
|
|
|
2922
|
독일
|
PEI: Information on Clinical Trials in Germany and Europe now Publicly Available, 07-Dec-2018 (German and English Versions)
|
2018.12.12
|
|
|
2921
|
독일
|
PEI: Registration Form According to §8d Abs.3 of the Law on Transfusion (TPG) for the reporting year 2018
|
2018.12.12
|
|
|
2920
|
독일
|
Guideline of 18-Dec-2008 on the Pre-ion of Drugs in Contract Medical Care
|
2018.12.11
|
|
|
2919
|
독일
|
Announcement of 10-Dec-2018: On Amendments According to §5 of the Decree on Determination and Labeling of Pack Sizes for Medicinal Products
|
2018.12.10
|
|
|
2918
|
브라질
|
Questions and Answers: Resolution RDC 242/2018 on Registration of Specific Medicinal Products
|
2018.12.10
|
|
|
2917
|
독일
|
BfArM Information Note: Requirements According to the Falsified Medicines Directive (Directive 2011/62/EC)
|
2018.12.08
|
|
|
2916
|
독일
|
BfArM: Information Note on the Electronic Declaration of Marketed Medicinal Products Not Requiring Marketing Authorization
|
2018.12.07
|
|
|
2915
|
독일
|
PEI Information Note: Requirements in Accordance with the Falsified Medicines Directive (Directive 2011/62/EC)
|
2018.12.07
|
|
|
2914
|
독일
|
G-BA Information Note: The Benefit Assessment of Pharmaceuticals in Accordance with the German Social Code, Book Five (SGB V), Section 35a
|
2018.12.07
|
|
|
2913
|
브라질
|
Public Consultation 572: Revocation of Obsolete Norms
|
2018.12.06
|
|
|
2912
|
미국
|
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
|
2018.12.05
|
|
|
2911
|
미국
|
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
|
2018.12.05
|
|
|
2910
|
미국
|
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment
|
2018.12.05
|
|
|
2909
|
브라질
|
Resolution RDC 64: The Common Denomination List of the Brazilian Pharmacopoeia
|
2018.12.04
|
|
|
2908
|
브라질
|
ANVISA News: New System for the Notification of Adverse Events with Medicinal Products and Vaccines to be Launched in December
|
2018.12.04
|
|
|
2907
|
브라질
|
Resolution RDC 251: Redefines ANVISA’s Structure
|
2018.12.04
|
|
|
2906
|
아르헨티나
|
Disposition 2089/2018: Documents to be Used as Proof of Commercialization for the Grant of Marketing Authorization within Decree 150/92
|
2018.12.04
|
|
|
2905
|
아르헨티나
|
ANMAT-MED CDF 001-00: Good manufacturing Practice Non-compliance Classification
|
2018.12.04
|
|
|
2904
|
브라질
|
Resolution RDC 20: Regulates About the Electronic Submission Procedure Applied to the Registration (Marketing Authorization) of New Medicinal Products
|
2018.12.04
|
|
|
2903
|
독일
|
PEI: C Rebuild - electronic submission of applications for batch release applications
|
2018.12.04
|
|
|
2902
|
브라질
|
Resolution RDC 253: Amends Resolution RDC 20/2013 on the Electronic Submission Procedure Applied to the Marketing Authorization of New Medicinal Products
|
2018.12.04
|
|
|
2901
|
미국
|
[의약품] 인체용 의약품 검토를 위한 『유익성-위해성 프레임워크(BRF)』 최신 동향(미FDA)
|
2018.11.29
|
|
|
2900
|
미국
|
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
|
2018.11.29
|
|
|
2899
|
미국
|
Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements
|
2018.11.29
|
|
|
2898
|
브라질
|
Resolution RDC 249: Amends the Common Denomination List of the Brazilian Pharmacopoeia
|
2018.11.28
|
|
|
2897
|
중국
|
일반화장품.화학의약품 중국 수출 허가 절차 간소화
|
2018.11.28
|
|
|
2896
|
브라질
|
Resolution RDC 39: Amends Resolution RDC 64/2012 on the Common Denomination List of the Brazilian Pharmacopoeia, 04-Apr-2014
|
2018.11.27
|
|
|
2895
|
아르헨티나
|
ANMAT-MED-BED 010-00: Guide for Scale Variations and Variations for Substances Subjected to the Demonstration of Bioequivalence
|
2018.11.27
|
|
|
2894
|
독일
|
BfArM FAQs: on Variations
|
2018.11.26
|
|
|
2893
|
대한민국
|
일반의약품 표준서식 작성요령 안내 및 협조요청
|
2018.11.21
|
|
|
2892
|
독일
|
Paul Ehrlich Institute Presentation: Organization Chart
|
2018.11.20
|
|
|
2891
|
독일
|
BfArM Form: Notification by the Pharmacovigilance Commissioner
|
2018.11.19
|
|
|
2890
|
독일
|
BfArM: Information Note on Joint Pilot Project for Treatment of Clinical Trial Applications with Medicinal Products for Human Use According to Regulation (EU) No 536/2014
|
2018.11.13
|
|
|
2889
|
독일
|
PEI Guidance on Notifications of Variations for Blood Components Used for Transfusion
|
2018.11.13
|
|
|
2888
|
독일
|
PEI Announcement of 19-Sep-2001: about the Introduction of a Blood Donation Master File for Fresh Frozen Plasma and Cell Blood Components
|
2018.11.13
|
|
|
2887
|
독일
|
PEI Information Note: Notice of Authorization for Medicinal Products - Ordering the use of the Online Database of the Paul Ehrlich Institute to Exclude Donations for the Production of Blood Preparations by Travelers Returning from Endemic Areas
|
2018.11.13
|
|
|
2886
|
아르헨티나
|
Disposition 1686/2018: Amends Disposition 8259/2017 wihch Determines the Reference Product for Performing Chemical and Physical Tests for Levothyroxine
|
2018.11.13
|
|
|
2885
|
독일
|
PEI Information Note on Support of the Development of New Medicinal Products and Innovative Concepts
|
2018.11.02
|
|
|
2884
|
브라질
|
Clarification Note 003/2017/GPBIO/GGMED/ANVISA: Interchangeability between Biosimilars and Comparator Biological Products
|
2018.10.31
|
|
|
2883
|
아르헨티나
|
Guidelines: Presentation of Planning of Applications for Effective Marketing Authorization of Biological Medicinal Products and Radiopharmaceuticals (FORM PAEC-B 1.1)
|
2018.10.31
|
|
|
2882
|
아르헨티나
|
Guidelines: Authorization for Commercialization of Biological Medicinal Products and Radiopharmaceuticals (FORM AECByR 1.1)
|
2018.10.31
|
|
|
2881
|
아르헨티나
|
FORM LVAC 1.1: Vaccines Batch Releases and Request to Export
|
2018.10.31
|
|
|
2880
|
아르헨티나
|
Guidelines: Vaccines Batch Releases and Request to Export (FORM LVAC 1.1)
|
2018.10.31
|
|
|
2879
|
아르헨티나
|
Guidelines: Submission of an Action Plan to Fulfill Requirements Post-MA Approval for Biological Medicinal Products or Radiopharmaceuticals (FORM PPRR-B 1.1)
|
2018.10.31
|
|
|
2878
|
아르헨티나
|
FORM REIS-B 1.1: Renewal of Biological Medicinal Products and Radiopharmaceuticals Marketing Authorizations
|
2018.10.31
|
|
|
2877
|
아르헨티나
|
Guidelines: Renewal of Biological Medicinal Products and Radiopharmaceutical Marketing Authorizations (FORM REIS-B 1.1)
|
2018.10.31
|
|
|
2876
|
아르헨티나
|
FORM SMF-B 1.1: Submission of SMF for Biologics or Radiopharmaceutical Companies
|
2018.10.31
|
|
|
2875
|
아르헨티나
|
Guidelines: Submission of SMF for Biologics or Radiopharmaceutical Companies (FORM SMF-B 1.1)
|
2018.10.31
|
|
|
2874
|
아르헨티나
|
FORM RRAD 1.1: Radiopharmaceuticals Marketing Authorization Application
|
2018.10.31
|
|
|
2873
|
아르헨티나
|
Guidelines: Guidelines for the Preparation of MA Applications for Radiopharmaceuticals (FORM RRAD 1.1)
|
2018.10.31
|
|
|
2872
|
아르헨티나
|
FORM APEX 1.1: Authorization of Manufacturing Sites Located Abroad for Biologics and Radiopharmaceuticals
|
2018.10.31
|
|
|
2871
|
아르헨티나
|
Guidelines: Authorization of Manufacturing Sites Located Abroad for Biologics and Radiopharmaceuticals (FORM APEX 1.1)
|
2018.10.31
|
|
|
2870
|
아르헨티나
|
Guidelines: Annual Update in the Composition of Viral Strains of Vaccines for Seasonal Influenza (FORM SAAC 1.1)
|
2018.10.31
|
|
|
2869
|
아르헨티나
|
FORM SAAC 1.1: Annual Update in the Composition of Viral Strains of Vaccines for Seasonal Influenza
|
2018.10.31
|
|
|
2868
|
독일
|
BMG Announcement of 23-Oct-2018: on Average Additional Contribution Rate of Statutory Health Insurance according to § 242a Abs 2 of the Fifth Book of the Social Code for Year 2019
|
2018.10.30
|
|
|
2867
|
아르헨티나
|
Request of Inspection to Obtain a GMP Certificate for Manufacturing Sites Located Outside Argentina
|
2018.10.24
|
|
|
2866
|
독일
|
PEI Form: Notification for Variations According to §29 par. 1 (1), par 1b and 1c of the AMG (German Drug Law) Application for Variations According to §29 par. 2a of the AMG for Parallel Imports
|
2018.10.23
|
|
|
2865
|
아르헨티나
|
Disposition 993/2018: Registration Certificate of Approved Pharmaceutical Products for Export Purposes
|
2018.10.23
|
|
|
2864
|
아르헨티나
|
Guidelines for the Preparation of MA Applications for Vaccines
|
2018.10.23
|
|
|
2863
|
독일
|
Guideline of 18-Dec-2008 on the Pre-ion of Drugs in Contract Medical Care (Arzneimittel-Richtlinie/AM-RL)
|
2018.10.23
|
|
|
2862
|
브라질
|
ANVISA News: Status of Brazil’s Adoption of ICH Guidelines
|
2018.10.23
|
|
|
2861
|
브라질
|
Technical Note 05/2018/GMESP/GGMED/ANVISA: Specifications for the Request of Brand Name Amendments
|
2018.10.23
|
|
|
2860
|
브라질
|
Guide: Investigation of Results Outside the Specifications
|
2018.10.16
|
|
|
2859
|
브라질
|
Evaluation Report: Drug Approval Document of BRINEURA (Cerliponase alfa)
|
2018.10.15
|
|
|
2858
|
미국
|
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
|
2018.10.15
|
|
|
2857
|
미국
|
Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft
|
2018.10.15
|
|
|
2856
|
브라질
|
Guide 9: Periodic Products Review
|
2018.10.12
|
|
|
2855
|
아르헨티나
|
Guidelines for Evaluators for the Assessment of Biological Medicinal Products Marketing Authorization Applications
|
2018.10.09
|
|
|
2854
|
브라질
|
Resolution RE 2.714: Composition of Influenza Vaccines for 2019
|
2018.10.09
|
|
|
2853
|
브라질
|
Evaluation Report: Drug Approval Document of IDELVION® (Albutrepenonacog alfa)
|
2018.10.09
|
|
|
2852
|
유럽연합
|
[국외 GMP관련규정] PIC/S GMP 부속서 (Annexes)
|
2018.10.05
|
|
|
2851
|
유럽연합
|
[국외 GMP관련규정]PIC/S GMP (Part 2)
|
2018.10.05
|
|
|
2850
|
유럽연합
|
[국외 GMP관련규정] PIC/S GMP (Part 1)
|
2018.10.05
|
|
|
2849
|
브라질
|
Questions and Answers: Registration Procedure for Industrialized Dynamized Medicinal Products
|
2018.09.28
|
|
|
2848
|
독일
|
PEI Press Release No. 18/2018: Messages On Side Effects of Medicines Easier to Report
|
2018.09.27
|
|
|
2847
|
독일
|
PEI Press Release No. 18/2018: Messages On Side Effects of Medicines Easier to Report
|
2018.09.27
|
|
|
2846
|
브라질
|
Guide: Medicinal Products Subjected to Simplified Notification
|
2018.09.27
|
|
|
2845
|
아르헨티나
|
Circular 4/2018: New Information to be Included in the Informed Consent Forms
|
2018.09.26
|
|
|
2844
|
독일
|
Decree of 21-Dec-2005: for the Reorganization of Pre-ion Obligation of Medicinal Products
|
2018.09.26
|
|
|
2843
|
독일
|
BfArM and PEI: Pharmacovigilance Bulletin, 3rd Issue
|
2018.09.24
|
|
|
2842
|
브라질
|
Communication CMED 15: Defines the Value of the Adaptive Reduction Price Coefficient (CAP)
|
2018.09.21
|
|
|
2841
|
독일
|
Announcement of 17-Sep-2018: On Amendments According to §5 of the Decree on Determination and Labeling of Pack Sizes for Medicinal Products
|
2018.09.20
|
|
|
2840
|
아르헨티나
|
Disposition 179/2018: Determines the Requirements for the Registration of Advanced Therapy Medicinal Products
|
2018.09.20
|
|
|
2839
|
브라질
|
Evaluation Report: Drug Not Approval Document of PIROXICAM (Piroxicam)
|
2018.09.20
|
|
|
2838
|
브라질
|
Evaluation Report: Drug Approval Document of CLORIDRATO DE CLORPROMAZINA (Chlorpromazine Hydrochloride)
|
2018.09.20
|
|
|
2837
|
브라질
|
Evaluation Report: Drug Not Approval Document of APIXABANA (Apixaban)
|
2018.09.20
|
|
|
2836
|
독일
|
Addendum I of 14-Sep-2018 to the Off-Label Use Expert Group Final Report of 13-Jul-2018: On the Use of Amantadine in Patients with Multiple Sclerosis in the Treatment of Fatigue
|
2018.09.18
|
|
|
2835
|
독일
|
Evaluation Report: Drug Not Approval Document of VIBERZI (Eluxadoline)
|
2018.09.17
|
|
|
2834
|
브라질
|
Communication CMED 14: Instructions for Filling the Commercialization Report
|
2018.09.14
|
|
|
2833
|
독일
|
Information Note: Approval of Clinical Trials Involving Genetically Modified Organisms (GMOs)
|
2018.09.13
|
|
|
2832
|
브라질
|
Evaluation Report: Drug Approval Document of KISQALI (Ribociclib Succinate)
|
2018.09.12
|
|
|
2831
|
아르헨티나
|
Checklist: Periodic Safety Update (PSURs) and Risk Management Reports
|
2018.09.12
|
|
|
2830
|
독일
|
Announcement of 16-Jan-2018: On Amendments According to §5 of the Decree on Determination and Labeling of Pack Sizes for Medicinal Products
|
2018.09.12
|
|
|
2829
|
독일
|
BfArM FAQs: Frequently Asked Questions on Electronic Submission According to AMG-EV
|
2018.09.12
|
|
|
2828
|
독일
|
BMG Announcement of 7-Sep-2018: On the Publication of the EU-GMP Guidelines in German According to §2 Nr.3 of the Decree Repealing the Operating Procedure for Pharmaceutical Companies (AMWHV)
|
2018.09.07
|
|
|
2827
|
브라질
|
Resolution RDC 104: Updates the Common Denomination List of the Brazilian Pharmacopoeia
|
2018.09.05
|
|
|
2826
|
브라질
|
Consultation 551: Good Pharmacovigilance Practices for Marketing Authorization Holders
|
2018.09.05
|
|
|
2825
|
브라질
|
Public Consultation 552: Sets Out Requirements for the Submission of Risk Evaluation Reports
|
2018.09.05
|
|
|
2824
|
브라질
|
Resolution RDC 247: Updates the Common Denomination List of the Brazilian Pharmacopoeia
|
2018.09.05
|
|
|
2823
|
브라질
|
Evaluation Report: Drug Approval Document of DESLORATADINA + SULFATO DE PSEUDOEFEDRINA (Desloratadine + Pseudoephedrine Sulfate)
|
2018.09.05
|
|
|
2822
|
독일
|
PEI: Paul-Ehrlich Institute Database for Observational Studies
|
2018.09.05
|
|
|
2821
|
대한민국
|
의약품 적정사용을 위한 주의 정보의 공고(식품의약품안전처공고 제2018-371호)
|
2018.09.05
|
|
|
2820
|
브라질
|
Resolution 2.416: Priority List for the Review of Administrative Appeals Submissions
|
2018.09.04
|
|
|
2819
|
브라질
|
Evaluation Report: Drug Approval Document of AGOMELATINA (Agomelatine)
|
2018.09.04
|
|
|
2818
|
브라질
|
Evaluation Report: Drug Approval Document of TRETINOÍNA (Tretinoine)
|
2018.09.04
|
|
|
2817
|
브라질
|
Evaluation Report: Drug Approval Document of BESILATO DE ANLODIPINO + ATENOLOL (Amlodipine besylate and Atenolol)
|
2018.09.04
|
|
|
2816
|
독일
|
PEI: Permission to Use of the PEI Online Database to Exclude Blood Donations of Travelers Returning from Endemic Areas
|
2018.09.04
|
|
|
2815
|
아르헨티나
|
Circular 3/2018: Special Conditions for Applications under Disposition 4622/12
|
2018.09.03
|
|
|
2814
|
독일
|
PEI Announcement of 01-Sep-2018: Directive on the Exclusion of Blood Donors to prevent Transmission of West Nile Virus by not Pathogen-Inactivated Blood Components
|
2018.09.03
|
|
|
2813
|
브라질
|
Resolution RDC 230: Updates the Common Denomination List of the Brazilian Pharmacopoeia
|
2018.09.03
|
|
|
2812
|
브라질
|
Resolution RDC 127: Updates the Common Denomination List of the Brazilian Pharmacopoeia
|
2018.09.03
|
|
|
2811
|
독일
|
BfArM: List of Educational Materials Publications on Active Substances and Medicinal Products
|
2018.09.01
|
|
|
2810
|
독일
|
BfArM FAQs: General Questions and Answers on Clinical Trials
|
2018.08.31
|
|
|
2809
|
아르헨티나
|
Instructions for the Use of the Electronic Payment System
|
2018.08.31
|
|
|
2808
|
|
최신 보건의료 빅데이터 법제 동향 조사분석
|
2018.08.30
|
|
|
2807
|
대한민국
|
의약품 안전성 정보지 발간 알림(61호)
|
2018.08.29
|
|
|
2806
|
대한민국
|
의약품 안전성 정보지 발간 알림(60호)
|
2018.08.29
|
|
|
2805
|
브라질
|
Evaluation Report: Drug Approval Document of BAVENCIO™ (Avelumab )
|
2018.08.27
|
|
|
2804
|
브라질
|
Evaluation Report: Drug Not Approval Document of LEVONORGESTREL + ETINILESTRADIOL (Levonorgestrel + ethinylestradiol )
|
2018.08.27
|
|
|
2803
|
브라질
|
Communication CMED 13: Establishes Factor Z (Intra-Sector Price Readjustment Factor) for 2019
|
2018.08.27
|
|
|
2802
|
대한민국
|
암피실린나트륨 설박탐나트륨 복합제(주사제) 허가사항 변경지시(통일조정) 사전예고 알림
|
2018.08.27
|
|
|
2801
|
대한민국
|
에녹사파린나트륨 단일제(주사제) 허가사항 변경지시(통일조정) 사전예고
|
2018.08.27
|
|
|
2800
|
브라질
|
Evaluation Report: Drug Not Approval Document of CLORIDRATO DE MELFALANA (Melphalan chloridrate)
|
2018.08.24
|
|
|
2799
|
브라질
|
Resolution RDC 246: Adds Some Substances and Medicinal Products Subjected to Special Control
|
2018.08.24
|
|
|
2798
|
일본
|
보건의료 빅데이터 활용을 위한 일본의 법제 동향 : 차세대의료기반법을 중심으로
|
2018.08.24
|
|
|
2797
|
대한민국
|
비칼루타마이드 단일제(정제) 허가사항 변경지시(통일조정) 사전예고
|
2018.08.23
|
|
|
2796
|
대한민국
|
클로피도그렐황산염 단일제(정제) 허가사항 변경지시(통일조정) 사전예고 알림
|
2018.08.23
|
|
|
2795
|
브라질
|
Evaluation Report: Drug Approval Document of RIVAROXABANA (Rivaroxaban)
|
2018.08.22
|
|
|
2794
|
브라질
|
Evaluation Report: Drug Approval Document of SULFATO DE HIDROXICLOROQUINA (Hydroxychloroquine Sulfate)
|
2018.08.21
|
|
|
2793
|
아르헨티나
|
Disposition 8398/2018: Bioequivalence: Requirements for Reference Product Designation/Similar Products
|
2018.08.21
|
|
|
2792
|
대한민국
|
이오헥솔 단일제(주사제) 허가사항 변경지시(통일조정) 사전예고 알림
|
2018.08.21
|
|
|
2791
|
브라질
|
Evaluation Report: Drug Not Approval Document of DEXAMETASONA + SULFATO DE NEOMICINA + SULFATO DE POLIMIXINA B (Dexamethasone; Neomycin Sulfate; Polymyxin B Sulfate)
|
2018.08.20
|
|
|
2790
|
브라질
|
Guide: Substantial Amendments to the Clinical Research Development Dossier for Medicinal Products (DDCM) and to the Clinical Trial Protocol, Suspensions and Cancellations, 16-Aug-2018 (Fourth Edition)
|
2018.08.20
|
|
|
2789
|
브라질
|
Evaluation Report: Drug Not Approval Document of CLORIDRATO DE FEXOFENADINA (Fexofenadine hydrochloride)
|
2018.08.20
|
|
|
2788
|
브라질
|
Evaluation Report: Drug Not Approval Document of CLORIDRATO DE SAXAGLIPTINA (Saxagliptin hydrochloride)
|
2018.08.20
|
|
|
2787
|
브라질
|
Evaluation Report: Drug Not Approval Document of VOSEVI (Sofosbuvir, Velpatasvir and Voxilaprevir)
|
2018.08.20
|
|
|
2786
|
브라질
|
Evaluation Report: Drug Approval Document of ENTECAVIR MONOIDRATADO (Entecavir Monohydrate)
|
2018.08.18
|
|
|
2785
|
브라질
|
Evaluation Report: Drug Approval Document of SOFOSBUVIR (Sofosbuvir)
|
2018.08.17
|
|
|
2784
|
독일
|
Introduction of a Blood Donation Master File for Fresh Frozen Plasma and Cell Blood Components
|
2018.08.15
|
|
|
2783
|
독일
|
BfArM FAQs: on Summaries of Risk Management Plans
|
2018.08.13
|
|
|
2782
|
브라질
|
Evaluation Report: Drug Approval Document of EVEROLIMO (Everolimus)
|
2018.08.10
|
|
|
2781
|
아르헨티나
|
Decree 733/2018: Electronic Document Management System
|
2018.08.10
|
|
|
2780
|
대한민국
|
희귀의약품 지정 공고
|
2018.08.10
|
|
|
2779
|
브라질
|
Evaluation Report: Drug Not Approval Document of DAPTOMICINA (Daptomycin)
|
2018.08.08
|
|
|
2778
|
브라질
|
Evaluation Report: Drug Not Approval Document of CLORETO DE SUXAMETÔNIO (Suxametonio chloride)
|
2018.08.07
|
|
|
2777
|
대한민국
|
「대한민국약전포럼(Vol.15, No.1)」발간 및 배포
|
2018.08.07
|
|
|
2776
|
모든국가,스위스,모든국가,모든국가,모든국가,일본
|
주요 규제당국 신약 승인 심사기간 분석
|
2018.08.06
|
|
|
2775
|
브라질
|
Evaluation Report: Drug Approval Document of VENCLEXTA (Venetoclax)
|
2018.08.03
|
|
|
2774
|
유럽
|
OECD GLP 지침서 번역본(1호, 2호, 3호)
|
2018.08.02
|
|
|
2773
|
일본
|
일본의 의약품 주요 규제현황
|
2018.08.02
|
|
|
2772
|
중국
|
한국과 중국의 의약품 인허가 체계비교
|
2018.08.02
|
|
|
2771
|
아르헨티나
|
Clinical Aspects Evaluation Report Template
|
2018.07.31
|
|
|
2770
|
미국
|
Assessing User Fees Under the Pre-ion Drug User Fee Amendments of 2017 Guidance for Industry
|
2018.07.31
|
|
|
2769
|
미국
|
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
|
2018.07.31
|
|
|
2768
|
미국
|
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling
|
2018.07.31
|
|
|
2767
|
미국
|
Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry
|
2018.07.31
|
|
|
2766
|
미국
|
Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act
|
2018.07.31
|
|
|
2765
|
미국
|
Pediatric HIV Infection: Drug Development for Treatment
|
2018.07.31
|
|
|
2764
|
미국
|
Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease
|
2018.07.31
|
|
|
2763
|
미국
|
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry
|
2018.07.31
|
|
|
2762
|
미국
|
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment
|
2018.07.31
|
|
|
2761
|
미국
|
Bioanalytical Method Validation Guidance for Industry
|
2018.07.31
|
|
|
2760
|
미국
|
Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application
|
2018.07.31
|
|
|
2759
|
미국
|
Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Considerations
|
2018.07.31
|
|
|
2758
|
미국
|
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax Guidance for Industr
|
2018.07.31
|
|
|
2757
|
미국
|
Complicated Intra-Abdominal Infections: Developing Drugs for Treatment
|
2018.07.31
|
|
|
2756
|
미국
|
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
|
2018.07.31
|
|
|
2755
|
미국
|
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry
|
2018.07.31
|
|
|
2754
|
미국
|
Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry
|
2018.07.31
|
|
|
2753
|
미국
|
Development of a Shared System REMS Guidance for Industry
|
2018.07.31
|
|
|
2752
|
미국
|
Complicated Urinary Tract Infections: Developing Drugs for Treatment
|
2018.07.31
|
|
|
2751
|
미국
|
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
|
2018.07.31
|
|
|
2750
|
미국
|
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
|
2018.07.31
|
|
|
2749
|
미국
|
Pre-ion Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief
|
2018.07.31
|
|
|
2748
|
미국
|
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff
|
2018.07.31
|
|
|
2747
|
미국
|
Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry
|
2018.07.31
|
|
|
2746
|
미국
|
Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
|
2018.07.31
|
|
|
2745
|
미국
|
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry
|
2018.07.31
|
|
|
2744
|
미국
|
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis
|
2018.07.31
|
|
|
2743
|
미국
|
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
|
2018.07.31
|
|
|
2742
|
미국
|
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry
|
2018.07.31
|
|
|
2741
|
미국
|
Pre-ion Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry
|
2018.07.31
|
|
|
2740
|
미국
|
Major Depressive Disorder: Developing Drugs for Treatment
|
2018.07.31
|
|
|
2739
|
미국
|
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry
|
2018.07.31
|
|
|
2738
|
미국
|
Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry
|
2018.07.31
|
|
|
2737
|
미국
|
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
|
2018.07.31
|
|
|
2736
|
미국
|
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments
|
2018.07.31
|
|
|
2735
|
미국
|
Slowly Progressive, Low-Pr-ence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies Guidance for Industry
|
2018.07.31
|
|
|
2734
|
브라질
|
Resolution RDC 24: Provisions on Specific Medicinal Products’ Registration, 14-Jun-2011
|
2018.07.26
|
|
|
2733
|
브라질
|
Resolution RDC 107: Amends Resolution RDC 199/06 which Establishes the Simplified Notification (Notificação Simplificada) for a List of Non-Pre-ion Medicinal Products
|
2018.07.26
|
|
|
2732
|
브라질
|
Normative Instruction 11: List of Non-Pre-ion Medicinal Products
|
2018.07.26
|
|
|
2731
|
브라질
|
Resolution RDC 242: Sets out Requirements for the Registration of Specific Medicinal Products
|
2018.07.26
|
|
|
2730
|
브라질
|
Normative Instruction 25: Therapeutic Indications for the Registration and Notification of Dynamized Medicinal Products
|
2018.07.25
|
|
|
2729
|
브라질
|
Normative Instruction 26: Strength Limits for the Registration and Notification of Dynamized Medicinal Products
|
2018.07.25
|
|
|
2728
|
브라질
|
Normative Instruction 27: Reference List for the Safety and Efficacy Evaluation of Dynamized Medicinal Products
|
2018.07.25
|
|
|
2727
|
브라질
|
Resolution RDC 238: Registration Procedure for Industrialized Dynamized Medicinal Products
|
2018.07.25
|
|
|
2726
|
독일
|
Announcement of 24-Jul-2018: Notifications on the Homeopathic Pharmacopoeia 2018 regarding (EU) 2015/1535
|
2018.07.24
|
|
|
2725
|
미국
|
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development
|
2018.07.23
|
|
|
2724
|
독일
|
BfArM Press Release No. 7/18: Cultivation of Cannabis on Medical Purposes
|
2018.07.20
|
|
|
2723
|
브라질
|
Evaluation Report: Drug Approval Document of FENDIZOATO DE CLOPERASTINA (Cloperastine fendizoate)
|
2018.07.19
|
|
|
2722
|
독일
|
BfArM FAQs: On National Variation Notifications, Purely National Variation Procedures
|
2018.07.18
|
|
|
2721
|
미국
|
Field Alert Report Submission: Questions and Answers Guidance for Industry
|
2018.07.18
|
|
|
2720
|
미국
|
Labeling for Biosimilar Products Guidance for Industry
|
2018.07.18
|
|
|
2719
|
미국
|
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry
|
2018.07.18
|
|
|
2718
|
미국
|
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials
|
2018.07.18
|
|
|
2717
|
미국
|
FDA, 바이오시밀러 조치계획(Biosiliars Action Plan;BAP) 발표
|
2018.07.18
|
|
|
2716
|
미국
|
Innovative Approaches for Nonpre-ion Drug Products
|
2018.07.17
|
|
|
2715
|
미국
|
FDA, 유전자치료제 개발 가이드라인 발표
|
2018.07.16
|
|
|
2714
|
독일
|
BfArM/PEI Announcement of 13-Jul-2018 on the Obligation to Notify a New Importation Country in Parallel Imported Medicinal Products According to § 29 of the German Drug Law (AMG)
|
2018.07.13
|
|
|
2713
|
미국
|
Q3D(R1) ELEMENTAL IMPURITIES
|
2018.07.13
|
|
|
2712
|
미국
|
Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry
|
2018.07.13
|
|
|
2711
|
아르헨티나
|
ANMAT Information Note: List of Applications to be Done Remotely
|
2018.07.12
|
|
|
2710
|
독일
|
PEI Information Note: Joint Commitment for the Availability of Vaccines
|
2018.07.10
|
|
|
2709
|
미국
|
Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention
|
2018.07.10
|
|
|
2708
|
브라질
|
ANVISA News: ANVISA to Finish up with the Waiting List for the Analysis of the Applications for Generics
|
2018.07.06
|
|
|
2707
|
미국
|
Indications and Usage Section of Labeling for Human Pre-ion Drug and Biological Products-Content and Format Guidance for Industry
|
2018.07.06
|
|
|
2706
|
브라질
|
Internal Circular 50/DIARE/ANVISA: Labelling Evaluation in Registration and Post-Registration Variations Applications
|
2018.07.05
|
|
|
2705
|
브라질
|
Evaluation Report: Drug Approval Document of PERINDOPRIL ERBUMINA + INDAPAMIDA (Perindopril erbumine + indapamide)
|
2018.07.04
|
|
|
2704
|
브라질
|
Evaluation Report: Drug Approval Document of ENTRICITABINA + FUMARATO DE TENOFOVIR DESOPROXILA (Emtricitabine + Tenofovir Disoproxil Fumarate)
|
2018.07.03
|
|
|
2703
|
미국
|
Abbreviated New Drug Application Submissions--Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act; Guidance for Industry
|
2018.07.03
|
|
|
2702
|
일본
|
Implementation of a Conditional Early Approval System for Pharmaceutical Products
|
2018.07.03
|
|
|
2701
|
대한민국
|
2018년도 상반기 분야별 자주 하는 질문집
|
2018.07.03
|
|
|
2700
|
독일
|
Regulation Adapting Pharmaceutical Provisions to the Delegated Regulation (EU)2016/161 from Commission on 02-Oct-2015: Supplementing Directive 2001/83/EC and Regulation (EU) 2016/679 on Processing Personal Data, Free Movement of Such Data, Repealing Directive 95/46/EC and Amending Drug and Pharmaceutical Legislation
|
2018.07.02
|
|
|
2699
|
브라질
|
Guide: Step by Step on the Submission of Import Applications Through the Electronic Platform (Version 4.3)
|
2018.07.02
|
|
|
2698
|
브라질
|
Evaluation Report: Drug Approval Document of BESILATO DE CISATRACÚRIO (Cisatracurium Besilate)
|
2018.07.02
|
|
|
2697
|
독일
|
BfArM Form: Template for Marketing Authorisation with Practical Advice for Completing
|
2018.06.30
|
|
|
2696
|
독일
|
BfArM FAQs: Frequently Asked Questions on Submission of National Translations in MR/DC Procedures
|
2018.06.30
|
|
|
2695
|
독일
|
BfArM Information Note on Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP)
|
2018.06.30
|
|
|
2694
|
독일
|
BfArM FAQs: Sunset Clause
|
2018.06.30
|
|
|
2693
|
브라질
|
Evaluation Report: Drug Approval Document of TORGENA® (Ceftazidime-Avibactam)
|
2018.06.29
|
|
|
2692
|
대한민국
|
「의약품 재평가 실시에 관한 규정 가이드라인」(민원인 안내서) 마련 알림
|
2018.06.29
|
|
|
2691
|
독일
|
BfArM and PEI: Pharmacovigilance Bulletin, 2nd Issue
|
2018.06.28
|
|
|
2690
|
독일
|
BfArM Information Note: State Cannabis Agency
|
2018.06.27
|
|
|
2689
|
브라질
|
Evaluation Report: Drug Approval Document of BILASTINA (Bilastine)
|
2018.06.27
|
|
|
2688
|
독일
|
BfArM Form: Notice of Observational Study, in Accordance with § 67, Section 6 of German Drug Law (AMG)
|
2018.06.22
|
|
|
2687
|
브라질
|
Communication CMED 07: Dismissal of Medicinal Products from the Index of Medicinal Products Market Follow up System
|
2018.06.22
|
|
|
2686
|
브라질
|
Resolution RDC 49: Sets forth Provisions for Variations (Postmarketing Changes), Suspension/Restarting of Manufacturing Activities and Withdrawals of Biological Products, 20-Sep-2011
|
2018.06.20
|
|
|
2685
|
브라질
|
Resolution RDC 11: Regulates the Import of Substances Subject to Special Control and Medicinal Products Containing Such Substances, 06-Mar-2013
|
2018.06.20
|
|
|
2684
|
브라질
|
Resolution RDC 38: Regulates the Post-Registration Procedures of Herbal Medicinal Products and Traditional Herbal Medicinal Products, 18-Jun-2014
|
2018.06.20
|
|
|
2683
|
브라질
|
Resolution RDC 17: Establishes the Good Manufacturing Practice Guidelines for Medicinal Products, 16-Apr-2010
|
2018.06.20
|
|
|
2682
|
브라질
|
Resolution RDC 62: Electronic Applications for Import and Export Authorizations of Substances and Medicinal Products Subject to Special Control, 11-Feb-2016
|
2018.06.20
|
|
|
2681
|
브라질
|
Resolution RDC 76: Post-Registration Variations Related to Specific Medicinal Products, 02-May-2016
|
2018.06.20
|
|
|
2680
|
브라질
|
ANVISA News: ANVISA to Enhance the Exchange of Information Regarding Commercial Names and Labeling for Non-Pre-ion Medicinal Products
|
2018.06.20
|
|
|
2679
|
브라질
|
ANVISA News: New Templates of the Declaration from the Product Regularization Holder for Third-Party Import
|
2018.06.20
|
|
|
2678
|
브라질
|
Resolution RDC 234: Sets out Requirements for the Outsourcing of the Production, Control and Transportation of Medicinal and Biological Products
|
2018.06.20
|
|
|
2677
|
브라질
|
Resolution RDC 231: Amends Order 344/1998 Technical Regulations for Substances and Medicinal Products Subject to Special Control
|
2018.06.20
|
|
|
2676
|
브라질
|
Resolution RDC 233: Amends RDC 102/2016 on Marketing Authorization and Clinical Trial Transfers
|
2018.06.20
|
|
|
2675
|
브라질
|
Resolution RDC 235: Establishes Quality Control Requirements for the Registration and Post-Registration of Dynamized, Herbal and Specific Medicinal Products and Biological Products
|
2018.06.20
|
|
|
2674
|
아르헨티나
|
ANMAT Information Note: ANMAT to Host Pan American Health Organization Meeting
|
2018.06.18
|
|
|
2673
|
독일
|
Regulation on Analgesic Warning Notice (Analgetika-Warnhinweis-Verordnung (AnalgetikaWarnHV))
|
2018.06.18
|
|
|
2672
|
독일
|
Off-Label Use Expert Group Draft Report of 15-Jun-2018: Bisphosphonate Therapy with Zoledronate or Clodronate
|
2018.06.15
|
|
|
2671
|
독일
|
PEI Information Note on WHO Certificates
|
2018.06.13
|
|
|
2670
|
독일
|
BfArM FAQs: Submission of Periodic Safety Update Reports (PSURs)
|
2018.06.08
|
|
|
2669
|
독일
|
BfArM Information Note: Brexit and Information Regarding Query of Associations in the Pharmaceutical Industry
|
2018.06.07
|
|
|
2668
|
독일
|
BfArM Form: Notification of Change of Pharmacovigilance Commissioner
|
2018.06.06
|
|
|
2667
|
브라질
|
Resolution RDC 201: Updates the Common Denomination List of the Brazilian Pharmacopoeia, 26-Dec-2017
|
2018.06.05
|
|
|
2666
|
독일
|
BfArM Announcement of 18-Jan-2016: on Alignment of Processing of National Authorization or Registration Applications of Medicines Production with Decentralized Authorization Procedure
|
2018.06.01
|
|
|
2665
|
폴란드
|
폴란드 의약품 규제
|
2018.06.01
|
|
|
2664
|
스위스
|
스위스 의약품 규제
|
2018.06.01
|
|
|
2663
|
노르웨이
|
노르웨이 의약품 규제
|
2018.06.01
|
|
|
2662
|
독일
|
BfArM FAQs: Frequently Asked Questions on Brexit
|
2018.05.31
|
|
|
2661
|
브라질
|
ANVISA`s Results for 2017
|
2018.05.31
|
|
|
2660
|
브라질
|
ANVISA 2017 Annual Report
|
2018.05.31
|
|
|
2659
|
아르헨티나
|
Disposition 5667/2018: Annual Maintenance Fees for Medicinal Products for 2017
|
2018.05.31
|
|
|
2658
|
모든국가,모든국가,미국
|
첨단 세포조직공학제제 해외 규제동향 2017
|
2018.05.31
|
|
|
2657
|
유럽
|
유럽 최신 약물감시 규정 자료집
|
2018.05.30
|
|
|
2656
|
독일
|
BfArM: Information for Manufacturers Regarding Application for Narcotic Legal License, According to Paragraph 3 of the Narcotics Law - Betäubungsmittelgesetz (BtMG)
|
2018.05.29
|
|
|
2655
|
브라질
|
Questions and Answers: Assessment Flow of Synthetic Innovator Medicinal Products Marketing Authorization Applications
|
2018.05.29
|
|
|
2654
|
미국
|
Trial Registration Laws
|
2018.05.24
|
|
|
2653
|
미국
|
Clinical / Antimicrobial
|
2018.05.24
|
|
|
2652
|
노르웨이
|
Information Note Reimbursement Application Fee, 14-Dec-2015
|
2018.05.24
|
|
|
2651
|
노르웨이
|
Guideline Transfer of the Marketing Authorisation Holder (MAH) from One Company to Another (Other Legal Entity), Nov-2015 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2650
|
노르웨이
|
Provision FOR-2004-11-02-1441 Manufacturing and Import of Medicinal Products (Consolidated Version up to FOR-2017-03-24-388), 24-Mar-2017
|
2018.05.24
|
|
|
2649
|
노르웨이
|
Guideline Tips and Advice for Applicants for Clinical Trials of Human Medicinal Products, 15-Sep-2014
|
2018.05.24
|
|
|
2648
|
노르웨이
|
Information Note Calculation of Added Costs to the National Insurance Administration When Pre-Approved Reimbursement Has Been Granted, 02-Jul-2015
|
2018.05.24
|
|
|
2647
|
노르웨이
|
Guideline for Wholesale Distribution Authorisation, Apr-2014
|
2018.05.24
|
|
|
2646
|
노르웨이
|
Outdated Information Note All Advertising for a Medicinal Product has to be in Accordance With the Approved Summary of Product Characteristics (SmPC), 22-Nov-2012
|
2018.05.24
|
|
|
2645
|
노르웨이
|
Report Form Fee on Sales, Jan-2015
|
2018.05.24
|
|
|
2644
|
노르웨이
|
Information Note Request Norway to Act as Reference Member State (RMS) in Decentralized Procedure (DCP), 13-Feb-2008 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2643
|
노르웨이
|
Application Form for Variation of an Authorisation for a Parallel Imported Medicinal Product, Sep-2006
|
2018.05.24
|
|
|
2642
|
노르웨이
|
Application Form for Renewal of an Authorisation for a Parallel Imported Medicinal Product, Sep-2006
|
2018.05.24
|
|
|
2641
|
노르웨이
|
Information Note Applications for Marketing Authorization Procedure, May-2015
|
2018.05.24
|
|
|
2640
|
노르웨이
|
Information Note Amendments in Clinical Trials, 12-Nov-2012
|
2018.05.24
|
|
|
2639
|
노르웨이
|
Information Note Scientific and Regulatory Advice for the Development of a Medicinal Product, 01-Mar-2014 (English and Norwegian Versions)
|
2018.05.24
|
|
|
2638
|
노르웨이
|
Information Note Rules for Content in Reminder Advertisements, 26-Feb-2015
|
2018.05.24
|
|
|
2637
|
노르웨이
|
Information Note Black Triangles in Advertising, 29-Jun-2016
|
2018.05.24
|
|
|
2636
|
노르웨이
|
Provision FOR-2009-10-30-1321 Clinical Trials of Medicinal Products in Humans, 30-Oct-2009 as Last Amended by Provision FOR-2013-04-22-408, 04-Jul-2013
|
2018.05.24
|
|
|
2635
|
노르웨이
|
PROVISION FOR-2006-02-17-263 Substances Which can be Used in Illegal Manufacturing of Narcotics, 17-Feb-2006 as Last Amended by Provision FOR-2013-02-14-199, 14-Feb-2013 (Last Update Nov-2016)
|
2018.05.24
|
|
|
2634
|
노르웨이
|
Guideline Routines Regarding Dispatch of Medicinal Products for Compassionate Use, Oct-2012
|
2018.05.24
|
|
|
2633
|
노르웨이
|
Information Note Electronic Recognition of Letters and Documents, 15-Mar-2013
|
2018.05.24
|
|
|
2632
|
노르웨이
|
Information Note Transition to New Wholesale Distribution Authorisation, Jul-2013
|
2018.05.24
|
|
|
2631
|
노르웨이
|
ACT LOV-2006-06-30-56 Ethics and Integrity in Research, 30-Jun-2006 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2630
|
노르웨이
|
Regulatory History Provision FOR-2009-12-18-1839 on Medicinal Products, 08-Nov-2017
|
2018.05.24
|
|
|
2629
|
노르웨이
|
Guideline Application for Pre-ion Requisition for a Medicinal Product without a Marketing Authorisation - Use of Electronic Application, 10-Oct-2014
|
2018.05.24
|
|
|
2628
|
노르웨이
|
Application Form for Marketing Authorisation for Parallel Imported Medicinal Product, May-2007 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2627
|
노르웨이
|
Information Note Some Medicinal Products are Exempted From the Negative List, Approval Exemption, 10-May-2013
|
2018.05.24
|
|
|
2626
|
노르웨이
|
Information Note Guidance concerning Banner Ads in Online Newspapers, 29-Jun-2016
|
2018.05.24
|
|
|
2625
|
노르웨이
|
Provision FOR-2009-10-30-1321 Clinical Trials of Medicinal Products in Humans, 30-Oct-2009 (Unamended Version)
|
2018.05.24
|
|
|
2624
|
노르웨이
|
Information Note Technical Leaflet Phased Out, 22-Mar-2013
|
2018.05.24
|
|
|
2623
|
노르웨이
|
Guideline Application for Pre-ion Requisition for a Medicinal Product without a Marketing Authorisation - Use of Paper Application, 10-Oct-2014
|
2018.05.24
|
|
|
2622
|
노르웨이
|
Information Note Reporting of Clinical Trials taking place in Norway, 12-Nov-2012
|
2018.05.24
|
|
|
2621
|
노르웨이
|
Application Form Application for Exemption from Withdrawal in Accordance with Legemiddelforskriften § 8-4 (Sunset Clause), Sep-2012 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2620
|
노르웨이
|
Outdated Guideline Price Setting in Norway, Jul-2015 (English and Norwegian Versions)
|
2018.05.24
|
|
|
2619
|
노르웨이
|
Report Form Fee on Medicinal Products Sold Outside Pharmacies, Jan-2015
|
2018.05.24
|
|
|
2618
|
노르웨이
|
Form Annual Report for Clinical Trial, Version 5.1, 26-Jun-2015
|
2018.05.24
|
|
|
2617
|
노르웨이
|
Form Additional Information when Suspected Adverse Reaction with Anticoagulants, May-2013
|
2018.05.24
|
|
|
2616
|
노르웨이
|
Guideline Variation Application in National Procedure Regarding Type II Variations in Section 4 and 5, 08-Jul-2011
|
2018.05.24
|
|
|
2615
|
노르웨이
|
Form Reporting of Suspected Adverse Reaction when Using Medicinal Products Including Herbal Medicines, 15-Dec-2016
|
2018.05.24
|
|
|
2614
|
노르웨이
|
Application Form Pre-ion Requisition for a Medicinal Product without a Marketing Authorisation, Sep-2014
|
2018.05.24
|
|
|
2613
|
노르웨이
|
Information Note Requirements for a New Marketing Authorisation Application, 17-Jul-2012
|
2018.05.24
|
|
|
2612
|
노르웨이
|
Information Note Recommendations on Safety Updates of Summary of Product Characteristics, Jan-2018
|
2018.05.24
|
|
|
2611
|
노르웨이
|
Outdated Guideline Product Information - Templates and Guidance, 15-Apr-2014 (English and Norwegian Versions)
|
2018.05.24
|
|
|
2610
|
노르웨이
|
Provisions FOR-2009-07-01-955 Organisation of Medical and Health Research, Jul-2009
|
2018.05.24
|
|
|
2609
|
노르웨이
|
Form Reporting of Suspected Adverse Reaction Following Vaccination, 13-Dec-2016
|
2018.05.24
|
|
|
2608
|
노르웨이
|
Information Note Public Disclosure of Information as Regards Marketing Authorisation, 17-Jul-2012
|
2018.05.24
|
|
|
2607
|
노르웨이
|
Information Note What should be added when applying for a New Clinical Trial 12-Nov-2012 (Updated 05-Mar-2015)
|
2018.05.24
|
|
|
2606
|
노르웨이
|
Price Application Form, 2015 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2605
|
노르웨이
|
Information Note Document Protection and Patent, Jan-2010
|
2018.05.24
|
|
|
2604
|
노르웨이
|
Application Form Import of Medicinal Products for Non-Medicinal Use, 03-Sep-2015
|
2018.05.24
|
|
|
2603
|
노르웨이
|
Guideline for Application on Authorisation of Parallel Imported Medicinal Products, 09-Mar-2007
|
2018.05.24
|
|
|
2602
|
노르웨이
|
Information Note Renewal of Marketing Authorisation, 18-Mar-2013
|
2018.05.24
|
|
|
2601
|
노르웨이
|
Information Note Registration Fees, Applicable from 15.6.2012, 12-Sep-2012
|
2018.05.24
|
|
|
2600
|
노르웨이
|
Guidelines to the Provision FOR-2009-10-30-1321 on Clinical Trials of Medicinal Products in Humans, 30-Oct-2009, Version 2.2, Updated 06-Oct-2012
|
2018.05.24
|
|
|
2599
|
노르웨이
|
Information Note Changes in Stepped Price System and Pharmacy Mark-Up Scheme - 2014, Jan-2014
|
2018.05.24
|
|
|
2598
|
노르웨이
|
Regulatory History Provision FOR-2004-11-02-1441 Manufacturing and Import of Medicinal Products, 16-Nov-2017
|
2018.05.24
|
|
|
2597
|
노르웨이
|
Information Note Reservation to the Change of medicinal products in the Pharmacy Including Parallel Imported, Updated on 29-May-2015
|
2018.05.24
|
|
|
2596
|
노르웨이
|
Provision FOR-2007-06-08-593 Ethics and Integrity in Research (Consolidated Version up to FOR-2015-02-13-122), 13-Feb-2015
|
2018.05.24
|
|
|
2595
|
노르웨이
|
Information Note Collaborative Solution for Medicines Approval, 29-Apr-2014
|
2018.05.24
|
|
|
2594
|
노르웨이
|
Guideline Notification of Deregistration or Withdrawal of a Medicinal Product, 24-Feb-2015
|
2018.05.24
|
|
|
2593
|
노르웨이
|
Guideline Pharmacoeconomic Analysis, 01-Mar-2012 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2592
|
노르웨이
|
Information Note Changes in the Routine for National Approval of Centrally Authorised Medicinal Products, 17-Dec-2013
|
2018.05.24
|
|
|
2591
|
노르웨이
|
Information Note Misuse of Medicinal Products as Side Effect, 30-Jan-2015
|
2018.05.24
|
|
|
2590
|
노르웨이
|
Outdated Information Note Registration of Brokers, 17-Dec-2014
|
2018.05.24
|
|
|
2589
|
노르웨이
|
Guideline Fee on Sales, Jan-2015
|
2018.05.24
|
|
|
2588
|
노르웨이
|
Guideline Naming of Medicinal Product, 24-Sep-2013 (English and Norwegian Versions)
|
2018.05.24
|
|
|
2587
|
노르웨이
|
Guideline Fee on Medicinal Products Sold Outside Pharmacies, 09-Jan-2015
|
2018.05.24
|
|
|
2586
|
노르웨이
|
Information Note Advertising for Medicinal Products, Jan-2018
|
2018.05.24
|
|
|
2585
|
노르웨이
|
Information Note Harmonization of PiLs and labelling for OTC-medicinal Products with an OTC Substance Report, 27-Feb-2015 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2584
|
노르웨이
|
Information Note Measures for Quality Failure in Medicinal Products, 03-Dec-2014
|
2018.05.24
|
|
|
2583
|
노르웨이
|
Information Note Application for Compassionate Use, 10-Nov-2017
|
2018.05.24
|
|
|
2582
|
노르웨이
|
Information Note Application for Exemption From Pre-ion - OTC Status, 05-Mar-2015
|
2018.05.24
|
|
|
2581
|
노르웨이
|
Form Application for a Manufacturing Authorisation for Investigational Sites - Investigational Medicinal Products, Relabeling of End-use Date, 11-Jul-2014
|
2018.05.24
|
|
|
2580
|
노르웨이
|
Guideline Health and Disease Information for the Pharmaceutical Industry in Advertisement Context, 08-Sep-2016
|
2018.05.24
|
|
|
2579
|
노르웨이
|
Outdated Information Note Overview of Entities that can Import Medicinal Products, 08-Jul-2015
|
2018.05.24
|
|
|
2578
|
노르웨이
|
Outdated Guideline Product Information - Templates and Guidance, 12-Nov-2014 (English and Norwegian Versions)
|
2018.05.24
|
|
|
2577
|
노르웨이
|
Form Request for Scientific and or Regulatory Advice, Jan-2017
|
2018.05.24
|
|
|
2576
|
노르웨이
|
Outdated Guideline Layout of the Labelling, Oct-2014
|
2018.05.24
|
|
|
2575
|
노르웨이
|
Guideline Preparation and Distribution of Training Material as a required Measure of Risk Minimization, 18-Nov-2014 (Version 3, Updated 19-Feb-2015)
|
2018.05.24
|
|
|
2574
|
노르웨이
|
Regulatory History Provision FOR-2009-12-18-1839 on Medicinal Products
|
2018.05.24
|
|
|
2573
|
노르웨이
|
Notification Form Interruption in Pharmaceutical Supply Medicine Shortage, 27-Feb-2015 (Norwegian and English Versions)
|
2018.05.24
|
|
|
2572
|
노르웨이
|
Note Use of Time-to-Event Data in Pharmacoeconomic Analyses, 13-Apr-2015 (English Version)
|
2018.05.24
|
|
|
2571
|
노르웨이
|
Outdated Information Note Submission of Applications, Jun-2015 (Norwegian and English Versions
|
2018.05.24
|
|
|
2570
|
노르웨이
|
Information Note Repealed Requirement for Wholesalers to provide a Full Range of Medicinal Products, 29-Apr-2015
|
2018.05.24
|
|
|
2569
|
노르웨이
|
Guideline Procedure for Request for Scientific and or Regulatory Advice, Nov-2015 (English and Norwegian Versions)
|
2018.05.24
|
|
|
2568
|
노르웨이
|
Guideline Changes in Labelling, Last Update 17-Aug-2016
|
2018.05.24
|
|
|
2567
|
브라질
|
ANVISA News: ANVISA Presents 2017 Annual Report
|
2018.05.23
|
|
|
2566
|
브라질
|
Resolution RDC 228: Sanitary Risk Management for Import Products under Sanitary Surveillance
|
2018.05.23
|
|
|
2565
|
브라질
|
Resolution RDC 81: Approves the Technical Regulations of Products Imported for Sanitary Surveillance, 05-Nov-2008
|
2018.05.23
|
|
|
2564
|
노르웨이
|
Outdated Information Note Wholesaler of Medicinal Products, 29-Apr-2015 (Updated 20-May-2015)
|
2018.05.23
|
|
|
2563
|
노르웨이
|
Outdated Information Note Remember to submit Written Drug Advertising to Electronic LMI Archive, 16-Feb-2015
|
2018.05.23
|
|
|
2562
|
노르웨이
|
Information Note Change of the Identification Number (Vnr.) when marketed Medicinal Product Trade Name changes, 01-Sep-2014
|
2018.05.23
|
|
|
2561
|
노르웨이
|
Guideline Technical Administration of Medicinal Products, 08-Sep-2016
|
2018.05.23
|
|
|
2560
|
노르웨이
|
Authorities Organizations Organization of Norwegian Medicines Agency (NoMA)
|
2018.05.23
|
|
|
2559
|
노르웨이
|
Information Note PSUR Repository becomes Mandatory, 08-Jun-2016
|
2018.05.23
|
|
|
2558
|
노르웨이
|
Form Application for a Wholesale Distribution Authorisation, Apr-2014 (English and Norwegian Versions)
|
2018.05.23
|
|
|
2557
|
노르웨이
|
Form Registration as a Broker in Norway, Dec-2014 (Norwegian and English Versions)
|
2018.05.23
|
|
|
2556
|
노르웨이
|
Guideline Content and Design of the Adverse Reaction Section of the Summary of Product Characteristics, 08-Mar-2016
|
2018.05.23
|
|
|
2555
|
노르웨이
|
Act LOV-1993-04-02-38 Manufacturing and Use of Gene Modified Organisms (Gene Technology Act) (Consolidated Version up to LOV-2015-06-19-65), 19-Jun-2015 (Last Update Nov-2016)
|
2018.05.23
|
|
|
2554
|
노르웨이
|
Information Note Notification of Marketing Interruption of a Medicinal Product Including Withdrawal, 13-Mar-2015 (Norwegian and English Versions)
|
2018.05.23
|
|
|
2553
|
노르웨이
|
Guideline Notification of Marketing Interruption of a Medicinal Product, 09-Mar-2015
|
2018.05.23
|
|
|
2552
|
노르웨이
|
Information Note Application for Batch Specific Changes, 22-Apr-2015
|
2018.05.23
|
|
|
2551
|
노르웨이
|
Provision FOR-1993-12-21-1219 Wholesale Activity with Medicinal Products (Consolidated Version up to FOR-2015-09-23-1096 and FOR-2015-12-18-1740), 18-Dec-2015
|
2018.05.23
|
|
|
2550
|
노르웨이
|
|