As a member of the Steering Committee of the ICH, Anvisa gains in decision-making power from the agency, going to have the right to participate in discussions and carry out proposals to the Assembly, among others.
Anvisa was elected to fill the last vacancy on the Steering Committee of the International Council on Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH). The decision was taken by the ICH Assembly at a meeting held on November 19 in Singapore after it was acknowledged that the Agency satisfactorily fulfilled the requirements set for the elective vacancy of a regulatory member.
The ICH brings together regulatory authorities and pharmaceutical industry associations to discuss technical and scientific aspects for drug registration. To date, the Council has developed over 60 guides on quality, safety, efficacy and multidisciplinary issues, including the Medical Dictionary for Regulatory Activities (MedDRA) and format standardization. Registration Form (Common Technical Document - CTD).
As a member of the ICH Steering Committee, Anvisa gains decision-making power from the ICH, enjoying the right to participate in discussions and make proposals to the Assembly on priority topics for harmonization, election of new members, supervision of working groups, training. , among others.
In addition, the position reached by the Agency favors a greater alignment of Brazilian drug legislation with international best practices. Thus, medicines registered by Anvisa will meet the same quality standard of products registered in the main international markets, thus bringing more security to society and competitiveness to the domestic market.
Mandate
Anvisa's mandate will last until 2021, during which time it will further develop ICH's activities, strengthening its position as a reference regulatory authority for the region. Anvisa is the sole authority in Latin America, a member of the ICH and a member of the ICH Steering Committee.
Composition
The ICH Steering Committee is made up of permanent members (United States, European Union, Japan, Canada and Switzerland) and there are four vacancies for elected members, of which three were filled in 2018 (South Korea, China and Singapore) and now , for Brazil.
Source: http://portal.anvisa.gov.br/noticias/-/asset_publisher/FXrpx9qY7FbU/content/anvisa-conquista-vaga-no-comite-gestor-do-ich/219201?p_p_auth=vTRFB6jj&inheritRedirect=false