Publication in the Federal Official Gazette
Anvisa (National Health Surveillance Agency) published Collegiate Board Resolution (RDC) No. 972/2025 in the Federal Official Gazette last Wednesday, April 23, 2025. The new text updates RDC 658/2022, which establishes the General Guidelines for Good Manufacturing Practices for Medicines in Brazil.
Main changes to RDC 658/2022
The main change brought about by RDC 972/2025 is in article 372. The new wording allows more flexibility for pharmaceutical companies:
- Optional online control:
The implementation of online control, provided for in article 215, may be waived upon technical justification, provided that the company adopts alternative control strategies based on quality risk management.
- Repeal of paragraphs:
Paragraphs 1 and 2 of article 372, which previously detailed specific requirements for online control, have been repealed.
When does the new resolution come into force?
RDC No. 972/2025 came into force on the date of its publication, i.e. on April 23, 2025.
Questions and Answers document not yet available
Anvisa had signaled during the 6th Ordinary Public Meeting, held on April 16, 2025, that the Questions and Answers document would be updated, especially with regard to the storage location of retention samples.
To date, this material has not been made available by the Agency. As soon as it is officially published, the information will be passed on to professionals and companies in the sector.
Recommended reading: Vote No. 86/2025/SEI/DIRE4/Anvisa
To better understand the context and arguments behind the changes, we recommend reading Vote No. 86/2025/SEI/DIRE4/Anvisa, approved during the meeting of April 16, 2025.
