Overview:
Confidentiality agreement between the two regulatory authorities confirms Anvisa’s recognition on the international scene.
Anvisa’s International Partnerships
Anvisa has a tradition in international articulation, with active participation in the most important global forums on regulatory convergence. The Agency also maintains permanent dialogue with the main regulatory authorities, both bilaterally and multilaterally (in the World Health Organization – WHO and in the Pan-American Health Organization – PAHO).
The Agency is the only authority from a developing country to integrate the Executive Committee of the International Coalition of Medicines Regulatory Authorities (ICMRA), which gathers the world’s main regulatory agencies. It is also a member of the Steering Committee of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), a forum that brings together regulatory authorities and pharmaceutical industry associations to discuss technical and scientific aspects of drug registration.
THE AGREEMENT WITH EMA
Anvisa signed on last Monday (February 22nd) a confidentiality agreement with the European Medicines Agency (EMA). Through this agreement, the two regulatory authorities established the commitment and conditions for sharing non-public information involved in their regulatory acts.
The act formalizes the cooperation that has strengthened over the past years between the agencies. In May 2020, Anvisa and EMA signed an ad hoc commitment to exchange confidential information related to products to fight the Covid-19 pandemic. This commitment has enabled important bilateral and multilateral technical dialogues. From now on, with the broad confidentiality agreement, technical cooperation extends to all areas of activity of both agencies.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.