## [INVIMA ASS-RSA-FM081: Updated Format for Pharmacological Evaluation of New Synthetic Medicine Molecules](/index%2ephp/mandate/invima-ass-rsa-fm081-updated-format-for-pharmacological-evaluation-of-new-synthetic-medicine-molecules) May 28, 2026 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. [Consult Now](/webform/consult%0A?url=https://preprod.freyrsolutions.com/index%2ephp/markdownify/node/13672) Source [https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologic…](https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/autorizacion-de-comercializacion-registros) Select Mandate HA [INVIMA](/index%2ephp/mandate-by-ha/invima) Select Mandate Function [Regulatory Affairs](/index%2ephp/mandate-by-function/regulatory-affairs)