Understand How the Changes in RDC 954/2024 Impact Drug Registration and How QR Group Assists International Manufacturers

With the entry into force of RDC 954/2024, the drug registration process undergoes significant changes. The rule revises and simplifies the regulatory procedure, promoting greater speed in the registration, post-registration and renewal processes. QR Group, a specialist in health product regulation, is ready to help international manufacturers ensure compliance with ANVISA, offering agile and secure solutions.

Impacts of RDC 954/2024 on the Registration of Medicines

The main objective of the new resolution is to simplify and speed up the processing of registrations of generic, similar, specific, dynamized, herbal medicines, radiopharmaceuticals and biologics that are linked to a petition for a drug already registered.

Among the main changes, the following stand out:

• “Clone” procedure: It links the new registration to the documentation of quality, safety and efficacy of a previously approved parent drug.
• Reduction of Documentary Requirements: Submitting fewer documents streamlines the regulatory process without compromising safety and quality.
• Speed in Evaluation: The administrative approach allows for a faster and more efficient flow for new registrations.

This modernization aims to ensure greater predictability and legal certainty for companies in the pharmaceutical sector, maintaining the quality standards required by ANVISA.

How QR Group Ensures Fast, Efficient Compliance

QR Group acts as a strategic partner for international companies looking to register their products in Brazil. With a highly qualified team and in-depth knowledge of ANVISA regulations, the company offers complete support for:

• Interpretation of the new guidelines and documentary adequacy.
• Petitioning and monitoring of the regulatory process.
• Strategies to optimize the approval time of records.
• Guarantee of compliance with the requirements of RDC 954/2024.

Speed Up Your Registration Process with QR Group

If your company needs to register or regularize medicines in Brazil and ensure compliance with the new guidelines of RDC 954/2024, QR Group has the ideal solution. Contact us to ensure an agile, safe and efficient process!

Glossary

• RDC: Resolution of the Collegiate Board of ANVISA.
• Mother Petition: Regulatory reference document for subsequent registrations.
• Clone Drug: Product that follows the standards of an approved parent drug.

Source: ANVISA