The Brazilian Health Regulatory Agency (Anvisa) issued Normative Instruction (IN) 292/2024, outlining the criteria and specific procedures for defining Equivalent Foreign Regulatory Authorities (AREEs) in sanitary inspections. This norm also establishes an optimized analysis procedure for Good Manufacturing Practices (GMP) certification. A recent correction to Article 4 of this norm has prompted an update from Anvisa.
Key Details of IN 292/2024
Purpose and Scope
IN 292/2024 aims to streamline the process of recognizing foreign regulatory authorities that meet Anvisa’s standards for sanitary inspections. By defining AREEs, Anvisa can adopt optimized analysis procedures, enhancing efficiency in GMP certification.
Article 4 Correction
The correction concerns §1º of Article 4, which mistakenly refers to the existence of Mutual Recognition Agreements (MRAs) between Anvisa and other international health authorities. Currently, Anvisa does not have such agreements in place. This discrepancy significantly affects the procedural integrity of recognizing AREEs.
Current State of International Cooperation
Anvisa collaborates with various international health authorities, as listed on their website. However, these collaborations do not extend to MRAs in GMP inspections and certifications. The AREEs designated in the annex of IN 292/2024 are selected based on criteria established in Article 3, allowing for optimized analysis under partial or full confidence levels.
Path to Mutual Recognition
The norm outlines a clear path to achieving mutual recognition:
- Regulatory Trust-Building Program: A structured program designed to build regulatory trust between Anvisa and foreign authorities.
- Directorate Board Deliberation: The Directorate Board (Dicol) must deliberate and approve the recognition process.
- Mutual Recognition Agreement (MRA) Signing: The final step involves the formal signing of an MRA, as detailed in § 3º of Article 4 and Article 6 of IN 292/2024.
Ongoing Corrections
Anvisa has initiated the process to correct the text of Normative Instruction 292/2024. The necessary amendments will soon be deliberated by Dicol to ensure clarity and accuracy in the norm.
Continuation of Optimized Analysis Procedure
Despite the need for textual corrections, Anvisa has assured that the protocol for petitions under specific subject codes for the optimized analysis procedure remains unaffected. This means that ongoing and future petitions can proceed without disruption, maintaining regulatory processes and GMP certification flows.
Conclusion
The correction of IN 292/2024 is a vital step in ensuring that Anvisa’s regulatory framework remains robust and accurate. By addressing the discrepancies in Article 4, Anvisa reaffirms its commitment to transparency and efficiency in international regulatory cooperation. Stakeholders are encouraged to stay informed about updates and continue with their petition submissions under the established procedures.