INVIMA updated ASS-RSA-FM081 on 28-May-2026 (original document date: 22-Dec-2025), introducing significant structural and content changes to the pharmacological evaluation format for new synthetic drug molecules.
Policy Focus:
- Comprehensive restructuring and expansion of the pharmacological evaluation submission format for new synthetic molecules.
Scope:
- Applicable to innovator pharmaceuticals, medicinal products, and medical gases submitted for new synthetic molecule evaluation before INVIMA.
Key Requirements / Provisions:
- Digital-First Process: Detailed electronic notification rules, user responsibilities, and legally binding timelines.
- Restructured Format: Complete renumbering and reorganization of sections for standardized submission.
- Expanded Data Requirements: More detailed pharmacological, clinical, and product information sections.
- Post-Marketing Data: Mandatory real-world and post-marketing data analysis including country-specific (Colombia) inputs.
- Enhanced RMP: Significantly improved Risk Management Plan with modular structure, risk tracking, and defined pharmacovigilance activities.
- Special Populations: Explicit documentation and justification required for special populations, missing data, and safety gaps.
Regulatory Goals:
- Strengthen pharmacological evaluation submissions for new molecules.
- Align with international standards.
- Improve pharmacovigilance integration from initial registration.
Source
Select Mandate HA
Select Mandate Function