Overview
On October 19th, 2023, Brazil's regulatory authority, Anvisa, issued RESOLUTION - RDC No. 823, establishing a pilot project for an optimized assessment procedure based on risk criteria. This procedure aims to assess the adequacy of documentation in medicine registration petitions and post-registration changes. Here are the key aspects explaining its effect:
Applicability
This resolution applies to Therapeutic Equivalence Centers, companies with registrations, and companies involved in medicine research, development, and manufacturing.
Stages of Evaluation
Registration petitions and post-registration changes can undergo:
- Qualified screening
- Screening
- Optimized assessment based on risk criteria
- Ordinary assessment
Treatment of Pending Issues
Petitions with pending issues identified after assessments will be handled according to their risk levels:
- High-risk issues: rejection without requirements
- Medium-risk issues: requirements
- Low-risk issues: approval with pending issues
Consideration of Inspection Results
The results of inspections conducted in Therapeutic Equivalence Centers before this resolution's enforcement may be considered in risk-based assessments.
Effective Date
This resolution went into effect on November 1st, 2023, and is valid until December 31st, 2026.
In summary, RESOLUTION - RDC No. 823 introduces a risk-based approach to evaluating medicine registration petitions and post-registration changes, focusing on documentation adequacy. It also provides a framework for addressing pending issues and considers past inspection results from Therapeutic Equivalence Centers, improving the regulatory process in Brazil.