New standard to approve evaluations from equivalent authorities. The standard establishes a simplified process for products (medicines, vaccines, biological products and pharmaceutical inputs) that have been approved by Foreign Regulatory Authorities Equivalent with regulations and practices equivalent to those of ANVISA.
The Agencies covered by the measure are:
I - European Medicines Agency – European Medicines Agency (EMA).
II - Canadian Health Agency – Health Canada.
III - World Health Organization – WHO.
IV - European Directorate for the Quality of Medicines & HealthCare (EDQM).
V - Swiss Agency for Therapeutic Products – Swissmedic.
VI – Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom.
VII - United States Regulatory Agency – US Food and Drug Administration (FDA).
VIII - Therapeutic Goods Administration (TGA) – Australia.
Read also: Drug Product Registration Process in Brazil
