ANVISA: Relying on International Evaluation Reports
The Brazilian health regulatory authority, ANVISA, has decided to consider evaluation reports from international regulatory bodies in their decision-making process.
This includes using the EDQM’s Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure. The other regulatory authorities/organisations concerned by this decision are the European Medicines Agency, Health Canada, the World Health Organization, Swissmedic, the UK Medicines and Healthcare products Regulatory Agency, the US Food and Drug Administration and the Australian Therapeutic Goods Administration.
Source:
EDQM: Newsroom
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