Governing medicinal products for human use in the Eurasian Economic Union

Governing medicinal products for human use in the Eurasian Economic Union : 작성자, 카테고리, 작성일, 조회수, 원문,출처, 정보 제공
작성자	임이슬	카테고리	전문가 인사이트
작성일	2017-09-13	조회수	3,375
원문
출처

글 Ravil Niyazov: GPKOL위원

경력사항

현재 Center of Scientific Advice Ltd. (Russia), Regulatory Affairs, Head

세부 전문분야

Regulatory affairs: Appropriate rules governing medicinal products for human use in Russia, EAEU, and EU
Clinical Trial: Scientific aspects of clinical development, medical writing
R&D 기획: Development of generic and biosimilar medicinal products; new chemical entities/biologics

Abstract

In this paper, some historical aspects regarding to how the single pharmaceutical market was found within the EAEU, the main document laying down the rules governing medicinal product for human use in the EAEU, including the relationship of those documents with European Union, ICH, EMA, WHO, MHRA, FDA, etc. laws, regulations, and guidelines, and regulatory aspects of applying for, or maintenance of, a marketing authorization for a medicinal product in the Eurasian Economic Union Member States will be described.

Introduction and history

The article discusses the Foundation of the Eurasian Economic Union and creation of harmonized principles for governing medicinal products for human use within the EAEU as well as the Rules of granting a marketing authorization and assessment of medicinal products for human use which govern the single market of pharmaceutical products within the EAEU.
The history of the Eurasian Economic Union begins with the Agreement on the Customs Union which was reached between Belarus, Kazakhstan, and Russian Federation in 1995. Later on, other Member States also joined the Union. Four years later, in 1999 the Treaty of the Customs Union and Eurasian Economic Space was signed into law by the founding states, namely Belarus, Kazakhstan, and Russia.
In late 2000, another treaty was adopted by those three, establishing the Eurasian Economic Community. In 2003, the Eurasian Economic Space was established.
However, all of these measures were political rather than economic. Consequently, in October of 2007, Belarus, Kazakhstan, and Russia concluded a new Treaty on the Customs Union. The Treaty became effective in 2010, but the customs procedures between countries were canceled in the middle of 2011 only. In November of 2011 the Declaration of the Eurasian Economic Integration was adopted, and from the beginning of 2012, the Eurasian Economic Space began operating. The main purpose of the integration was to remove barriers to mutual trade. In May 2014, the Treaty of the Eurasian Economic Union was concluded, and beginning from January of 2015 the EAEU started functioning.
More detailed information on the EAEU can be found elsewhere.
Currently, there are five Member States in the EAEU. Three of them, the Republic of Belarus, the Republic of Kazakhstan, and Russian Federation, are the founding Member States which conceived the Union. The two other Member States, Kyrgyzstan and Armenia, joined the Union later on, in 2014 and 2015 respectively.

The Agreement on the medicinal products circulation in the EAEU

The Single Market of medicinal products for human use was established by the Agreement on the common principles and rules of medicinal products circulation within the Eurasian Economic Union in December of 2014 [1]. The Agreement laid down the main principles governing human medicinal products as well as the main terms and definitions related to the area of human pharmaceuticals. Those main principles are outlined in the appropriate articles of the Agreement. The following core principles of governing medicinal products for human use include:

Governance of medicinal products shall be based on international standards. In this regard, the European Union’s legal framework is considered the main benchmark while other legal systems play a supplementary role.
Functioning of the Common Market of medicinal products within the Union shall be based on GxP.
Harmonization of the pharmacopoeial standards of the Member States shall take place.
Non-clinical and clinical studies and trials in the Member States shall be conducted in accordance with GLP and GCP principles.
Granting a marketing authorization and assessment of medicinal products in the Member States shall be carried out using harmonized rules.
Product information shall also be harmonized.
Manufacturing of medicinal products shall be in accordance with GMP.
GxP inspections shall be conducted using harmonized standards.
Wholesale distribution, transportation, and storage of medicinal products shall be in accordance with GDP.
Pharmacovigilance activities shall be conducted in accordance with GVP.
Official supervision of medicinal products is also subject to harmonization between the Member States.
The Common Register of Authorized Medicinal Products of the Eurasian Economic Union and information databases in the area of medicinal products, as well as the Union Information System in the area of medicinal products, shall be created to facilitate management and oversight of medicinal products.
The procedure for communication between competent authorities of the Member States where restrictions on medicinal products have been imposed shall be established.
Cooperation between competent authorities of the Member States shall take place.

All those principles are detailed in the appropriate regulations and requirements which have been adopted under the Agreement. We will review these regulations and requirement further on. Similar agreements were reached in the area of medical devices and veterinary medicinal products.
Thus, the Agreement on the common principles and rules of medicinal products circulation within the Eurasian Economic Union envisages adoption of a number of second-level regulations which detail the requirements, rules, procedures, and guidance for development, authorization, and life-cycling of medicinal products for human use. Those documents will be considered next in the order they have been adopted by the legal bodies of the Eurasian Economic Union.

[1] Agreement between the Republic of Belarus, the Republic of Kazakhstan, and Russian Federation of 23 December 2014 on the common principles and rules of medicinal products circulation within the Eurasian Economic Union. URL: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/konsultComitet/Documents/Sogl_LS_Itog.pdf [accessed 11/09/2017].

Rules of authorization and assessment

In November of 2016, when all disagreements between the Member States were resolved. The main issue of disagreement concerned the interchangeability of medicinal products. The decision was postponed and will be considered in the future since the model suggested by Russia is inoperable.
The adopted document forms the legal and operational environment for the Single Market to function within. The Rules for granting a marketing authorization and assessment of medicinal products for human use [2] lay down the legal framework for marketing authorization procedures and lifecycling procedures (including renewal and variation) for medicinal products for human use. They also envisage upgrading the MAA dossiers of medicinal products authorized via national procedures to bring those dossiers into compliance with the Union requirements. Authorization procedures somewhat resemble those of the European Union. However, only two of four EU procedures will be used in the EAEU in the near future, namely the mutual recognition and decentralized procedure. Thus, neither the national procedure nor centralized procedure is envisaged so far, but many stakeholders hope that the CAP will be created in the future.

[2] Decision of the Council of the Eurasian Economic Commission of 3 November 2016 #78 on the Rules for granting a marketing authorization and assessment of medicinal products for human use. URL: https://docs.eaeunion.org/docs/ru-ru/01411969/cncd_21112016_78 [accessed 11/09/2017].

Rules of granting an authorization and assessment

The main principle of creating Union legislation is using foreign experience. The legal system which is most relevant to the Eurasian Economic Union model is that of the European Union. This is why principles and provisions outlined in EU legislation were used to create the Rules. The main source document underlying the Rules is Directive 2001/83 of the EU. For instances, provisions laying down the imposition of post-marketing measures; renewal of a marketing authorization; variation to the marketing authorization; suspension or revocation of a marketing authorization were directly sourced from the Directive.
The Rules have 20 appendices; most of them represent the adapted translation of EU/EC/EMA legal acts and guidelines.
In the remaining part of the article, the content and the sources of the appendices to the Rules will be descrided.

The first Appendix outlines the requirements for a marketing authorization application dossier. It was drafted based on Annex I of Directive 2001/83 as amended and Annex II of Chapter 1 - Marketing Authorization, Vol. 2A, EudraLex.
The second Appendix contains application templates for a marketing authorization for a medicinal product, variation applications, renewal applications, etc. It was derived from the EU Application Forms, Volume 2B - Presentation and content of the dossier, EudraLex.
Appendix 3 provides guidance on drafting a normative document accompanying an application for a marketing authorization. This is a type of a document used in Belarus, Kazakhstan, and Russia only, so no foreign sources are available.
Appendix 4 lays down requirements for a marketing authorization application dossier in the Common Technical Document (CTD) format. This is based on Appendix 1, so indirectly the source is the Annex I to Directive 2001/83.
Appendix 5 describes the Organization of the Common Technical Document for the registration of pharmaceuticals for human use, and it represents the direct translation of ICH M4 Organization of the Common Technical Document for the registration of pharmaceuticals for human use.
Appendix 6 provides a template for Critical Assessment Report, Non-Clinical Aspects and was drafted based on the EMA Day 80 assessment report - Non-clinical template.
Appendix 7 provides a template for Critical Assessment Report, Non-Clinical Aspects and was drafted based on the EMA Day 80 assessment report - Clinical template.
Appendix 8 provides a template for Critical Assessment Report, Quality Aspects, and it is based on EMA Day 80 assessment report - Quality template and the EMA Active substance master file (ASMF) assessment report template.
Appendix 9 provides a New active substance status template for Critical assessment report on the claim of new active substance status, and it is based on the EMA Day 80 assessment report - New active substance status template
Appendix 10 outlines the Active Substance Master File Procedure which was adapted from the EMA Guideline on Active Substance Master File Procedure
Appendix 10 outlines the Active Substance Master File Procedure which was adapted from the EMA Guideline on Active Substance Master File Procedure
Appendix 12 provides a test report template. The template is to be completed by the reference Member State’s control laboratory carrying out verification of test method included in the specification of the finished product. This does not have any sources as it pertains to local aspects of authorization procedures.
All the templates are for use by the regulatory authorities.
Appendix 13, 14, and 15 represent the guidance documents on the content of the critical assessment report on non-clinical, clinical, and quality aspects. They are intended to complement the appropriate template and are based on the appropriate EMA guidance documents.
Appendix 16 provides an overview template for Critical assessment report on Safety, Efficacy, and Quality and is based on the EMA Day 80 assessment report - Overview template.
Appendix 17 provides a template for a Certificate of marketing authorization for a medicinal product for human use. No foreign sources were used to draft the document.
Appendix 18 provides a Member State concerned comments template, and it is adapted from the CMDh Concerned Member State Comments on Day 70 Preliminary Assessment Report.
Appendix 19 outlines the Rules concerning the processing of variations to the terms of marketing authorizations for medicinal products for human use and is adapted from the European Commission Regulation (EC) N 1234/2008 as amended and the Annex to the European Commission Guidelines on the details of the various categories of variations.
Appendix 20 is complementary to Appendix 20 and outlines the Rules concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use. The Appendix is based on the main text of the European Commission Guidelines on the details of the various categories of variations etc.
Appendix 21 provides a template for type I Variation Critical Assessment Report and is based on the EMA template for rapporteur Type II variation assessment report.
Appendices 22 and 23 provide a template and a guidance complementary to the template on the content of critical assessment report for non-clinical and clinical aspects of generic medicinal products. The appendices are adapted from the EMA Day 80 assessment report - Generic clinical and non-clinical template.

Conclusion

Thus, Eurasian Economic Union Member States have created a new Single Pharmaceutical Market. In order to the Single Market operate properly, the Rules of granting a marketing authorization and assessment of medicinal products for human use were established which are quite robust but need to be improved to achieve the level which will be equivalent to that effective in developed countries. The main benchmark is the European Union rules. Currently, great efforts are being made to complement the rules with other documents and procedures.

[1] Agreement between the Republic of Belarus, the Republic of Kazakhstan, and Russian Federation of 23 December 2014 on the common principles and rules of medicinal products circulation within the Eurasian Economic Union. URL: http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/konsultComitet/Documents/Sogl_LS_Itog.pdf [accessed 11/09/2017].

[2] Decision of the Council of the Eurasian Economic Commission of 3 November 2016 #78 on the Rules for granting a marketing authorization and assessment of medicinal products for human use. URL: https://docs.eaeunion.org/docs/ru-ru/01411969/cncd_21112016_78 [accessed 11/09/2017].

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