São Paulo — Anvisa and the Pharmaceutical Industry Union (Sindusfarma) held the 2nd Workshop Points of attention on regulatory requirements for clinical development and registration of drugs on September 15, in a hybrid format, with about 450 participants.

Representatives from Anvisa’s clinical research and drug registration areas reviewed common deficiencies found in dossiers, especially in documents such as the Investigator’s Brochure, Experimental Drug Dossier, Specific Clinical Trial Dossier, and Statistical Analysis Plans.

The discussions were based on RDC 948/2024 (sanitary requirements for human-use medicines) and RDC 753/2022 together with IN 184/2022 (on synthetic and semi-synthetic drug registration), also noting the impact of RDC 945/2024, IN 338/2024 and Law 14.874/2024 since their enforcement starting in January 2025.

Anvisa will consolidate the workshop’s outcomes into a Q&A document to guide the regulated sector.

Source: Anvisa

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