The Brazilian National Health Regulatory Agency (Anvisa) has announced a new initiative to expedite the certification process for Good Manufacturing Practices (GMP). In a move towards greater regulatory reliance, Anvisa will now consider inspections conducted by equivalent foreign regulatory bodies (AREEs). This new approach, outlined in Normative Instruction (IN) 292/2024 published on April 3rd, 2024, is expected to significantly reduce processing times for applications.
What is Regulatory Reliance?
Regulatory reliance leverages the work of reputable foreign regulatory agencies. By trusting the evaluations conducted by these agencies, Anvisa can streamline its own inspection procedures for certain products. This reduces duplication of effort and expedites the overall certification process.
How Will This Affect Businesses?
Companies seeking GMP certification for medications, biological products, cannabis for medicinal purposes, and active pharmaceutical ingredients (APIs) will benefit from this new approach. Applications that involve products already approved by recognized AREEs can potentially see faster processing times.
Anvisa Defines Three Levels of Reliance
IN 292/2024 establishes three tiers of reliance, allowing Anvisa to tailor its review process based on the specific AREE involved:
- Partial Reliance: A complete analysis of the inspection report issued by the AREE is conducted to assess compliance with GMPs. Anvisa can adopt the findings unilaterally.
- Full Reliance: A simplified review of the AREE’s inspection report is undertaken. Anvisa maintains the authority to make a unilateral decision based on this review.
- Mutual Recognition: Through a formal agreement and established program of regulatory reliance, Anvisa and the AREE will fully recognize each other’s GMP inspections and certificates.
A Streamlined Future for GMP Certification
The adoption of regulatory reliance signifies a significant step forward for Anvisa. By leveraging the expertise of trusted foreign authorities, Anvisa can enhance efficiency in the certification process while upholding its commitment to rigorous quality standards. This initiative is expected to benefit both businesses and consumers by accelerating access to safe and effective medical products.
IN 292/2024 comes into effect on June 1st, 2024. Companies interested in utilizing this streamlined process can inquire with Anvisa using the relevant code.
