In a decision advancing international convergence in pharmaceuticals worldwide, the Brazilian health regulatory authority, Agência Nacional de Vigilância Sanitária (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 to support the evaluation of the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA) applications used in marketing authorisation applications for medicinal products . This agreement builds upon two memoranda of understanding between ANVISA and the EDQM signed in 2014 and 2017, by virtue of which the Brazilian Pharmacopeia became an observer to the European Pharmacopoeia Commission.
This step will not only help optimise internal procedures for the evaluation of medicinal products and active pharmaceutical ingredients but will also facilitate the authorisation of medicines on the Brazilian market and improve access to healthcare. The EDQM looks forward to expanding co-operation with ANVISA.
The decision also supports the EDQM’s strategic goal of expanding its outreach and impact worldwide. By encouraging international co-operation and harmonised standards for medicines, the EDQM strengthens its pivotal role in global pharmaceutical regulation.
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.
ANVISA is the Brazilian regulatory agency responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services and medical devices, among others.
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