On March 19th, during a public meeting of the Collegiate Board of Directors, the Brazilian health regulatory agency ANVISA approved a Normative Instruction that establishes criteria and procedures for using the analyses carried out by an Equivalent Foreign Regulatory Authority (EFRA)
The optimized analysis procedure applies to the marketing and post-marketing authorizations for medicinal products, active pharmaceutical ingredients (APIs), and biological products and their active substances, as well as for the issuance of an Active Pharmaceutical Ingredient Dossier Adequacy Letter (CADIFA).
Also known as regulatory reliance, the rule establishes a simplified procedure for products that have been approved by at least one foreign regulatory authority with regulations and practices equivalent to those of ANVISA.
The criteria outlined in the Normative Instruction follows established principles that ensure the integrity and effectiveness of regulatory processes. These include the complete submission of the required documents, compliance with current Brazilian legislation, and the demonstration of equivalence between products approved by EFRAs and those submitted for evaluation by ANVISA.
It is important to note that, following the approval of RDC 750/2022, a pilot phase commenced in August 2022. This phase aimed to test the viability of the new model, gather relevant information, and assess experiences. Based on the results obtained, it was clear that companies showed significant interest in the new measure. In the period from September 2022 to February 2024, 408 dossiers were submitted for the registration and registration amendment of biological, synthetic, and semi-synthetic medicines, as well as CADIFAs dossiers, via reliance. Of these 408 dossiers, 211 were approved.
The new rules approved in the Normative Instruction were published in the Official Gazette on March 25th and will come into force on April 1st. In this sense, ANVISA has already indicated the EFRAs that will be covered by the simplified procedure.
- List of Equivalent Foreign Regulatory Authorities (EFRAs) covered by the measure:
I – 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 – US Food and Drug Administration (FDA).
VIII – Australian Therapeutic Goods Administration (TGA)
If you have any questions or would like to get more information, do not hesitate to get in touch with our regulatory team. We will be glad to assist you.