The Brazilian Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) was accepted in the International Program for the Rationalization of Inspections of Good Manufacturing Practices (GMP) of Active Pharmaceutical Ingredients (API), called API Cluster.

The official communication of the successful completion of the Agency’s adhesion to the Program was published by European Medicines Agency (EMA) on September 17th, 2021.

With this, Brazil becomes part of a group formed by several countries that work in an articulated way to perform inspections and share information.

In addition to Brazil, the following authorities are also part of the program:

France (National Agency for Medicines and Health Products Safety – ANSM)

Denmark (The Danish Medicines Agency – DKMA)

Ireland (Health Products Regulatory Authority – HPRA)

Italy (Italian Medicines Agency – AIFA)

United Kingdom (Medicines & Healthcare Products Regulatory Agency – MHRA)

European Union (The European Directorate of the Quality of Medicines and Healthcare - EDQM)

United States of America (Food and Drug Administration – FDA)

Australia(Therapeutic Goods Administration – TGA)

Canada (Health Canada)

Japan (Pharmaceuticals and Medical Devices Agency – PMDA)

World Health Organization (WHO).

The entry of the ANVISA into the program reinforces all the actions of international regulatory convergence that the agency has been pursuing over the years. It is important to mention that ANVISA has been recently admitted to the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

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