On December 2, 2024, the National Directorate of Sanitary Surveillance (DINAVISA) introduced the “Guide to Good Evaluation Practices for the Registration of Medicines.” This guideline represents a major update to the regulatory framework, focusing on ensuring the quality, safety, and efficacy of pharmaceutical products through clear and transparent evaluation processes.
The guide aims to align DINAVISA’s procedures with international standards, fostering harmonization with global regulatory norms. It applies to all pharmaceutical products intended for human use, including drugs, biologics, chemicals, reagents, medical devices, and personal hygiene products classified as cosmetics or sanitizers.
Key highlights of the guideline include:
- Adherence to international standards and best practices for medicinal product evaluation.
- Detailed compliance requirements for every stage of product development, including pre-clinical studies, clinical trials authorization, post-marketing modifications, and re-registration processes.
- Emphasis on a multidisciplinary approach that integrates non-clinical, clinical, biocompatibility, manufacturing processes, and risk management evaluations.
- Mechanisms to leverage evaluations conducted by recognized international regulatory authorities to expedite reviews while maintaining stringent safety and efficacy standards.
- A focus on fostering continuous professional development and critical thinking among evaluators to ensure evidence-based decisions grounded in current scientific understanding.
The new guide is a significant step toward modernizing and streamlining the pharmaceutical marketing authorization process, ensuring regulatory decisions are consistent, transparent, and aligned with global practices.
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