Key Changes and Impacts for Drug Manufacturers
The recent update of RDC 954/2024 brought significant changes to the simplified procedure for registering medicines in Brazil. In an exclusive event held by ANVISA on March 13, experts discussed the main guidelines and their impacts on the pharmaceutical sector. QR Group has closely followed the news to continue helping companies in the regularization of their products in an agile and safe way.
What has changed with RDC 954/2024?
RDC 954/2024 updates and simplifies the process of registering medicines, making regularization more efficient and transparent. Among the main points addressed at the event, the following stand out:
- Reduction of bureaucracy for the registration of certain medicines, facilitating the entry of new products into the market.
- New eligibility criteria for the simplified procedure, expanding the possibilities of framing.
- Clearer and more predictable deadlines for the analysis of registration processes, providing greater regulatory certainty.
- Integration with ANVISA’s digital systems, making the petition more dynamic and accessible.
How can QR Group help your company?
With the new guidelines, companies that want to register medicines in Brazil need to ensure compliance with the updated requirements. QR Group, a specialist in sanitary regulation, offers strategic support to national and international manufacturers, ensuring that the registration process takes place efficiently and within ANVISA’s requirements.
Our team of experts works in the technical analysis of regulatory requirements, preparation of dossiers and monitoring of processes with the regulatory agency. In this way, your company reduces risk, optimizes time, and ensures a successful registration.
If your company needs support to adapt to the new requirements, count on QR Group. Contact us and find out how we can facilitate your regulatory process with ANVISA.
Source: ANVISA
