INVIMA ASS-RSA-FM080: Updated Evaluation Format for New Association, Pharmaceutical Form and Concentration of Synthetic Medicines

INVIMA updated ASS-RSA-FM080 on 28-May-2026 (original document date: 22-Dec-2025), introducing functional changes to the pharmacological evaluation format for new associations, pharmaceutical forms, and concentrations of synthetic medicines.

Policy Focus:

• Updated submission format for pharmacological evaluation of new associations, pharmaceutical forms, and concentrations of synthetic medicines.

Scope:

• Applicable to medicinal products submitted for evaluation of new associations, new pharmaceutical forms, or new concentrations before INVIMA.

Key Requirements / Provisions:

• Electronic Notification: Mandatory consent with email and legal basis.
• Expanded Details: Active ingredient with concentration; clearer manufacturer/importer/holder sections.
• Redesigned Request Section: Includes classification, antecedentes, and tracking of prior or ongoing evaluations.
• Pharmacological Section: Enhanced with special populations and requirement to align with prescribing information.
• New Documentation: Risk management plan requirement added; internal evaluation/decision sections removed from form.
• Application Types: New association, new pharmaceutical form, new concentration, and response to requirements.

Regulatory Goals:

• Standardize pharmacological evaluation submissions for synthetic medicine modifications.
• Strengthen risk management integration from submission stage.
• Improve traceability of prior regulatory antecedents.