INVIMA updated ASS-RSA-IN56 on 26-May-2026 (original document date: 11-Feb-2026), significantly expanding the scope and content requirements for user inserts, prescribing information (IPP), and safety and efficacy modification submissions.
Policy Focus:
- Expanded scope and strengthened content requirements for user inserts, prescribing information (IPP), and safety/efficacy modification submissions for biologics, medicinal products, and medical gases.
Scope:
- Applicable to marketing authorization (sanitary registration) applications and post-approval modifications for biological medicines, chemical synthesis drugs, and medicinal gases.
Key Requirements / Provisions:
- Expanded Scope: Now covers sanitary registration applications, not just post-approval modifications.
- SPC Alignment: Prescribing information aligned with SPC format with standardized structure.
- Detailed Indications: Requirements for target population and treatment intent including genotype/age specificity.
- Interactions & Dosage: Expanded requirements including washout periods, dose adjustments, special populations, and detailed administration guidance.
- Adverse Reactions: Stricter rules for wording; vague or non-evidence-based statements prohibited.
- Evidence Standards: Robust scientific evidence required for all claims; strict alignment with approved registration content.
- New Submission Formats: Addition of new/expanded submission framework and formats.
Regulatory Goals:
- Harmonize insert and prescribing information standards across product categories.
- Strengthen evidence requirements for labelling content.
- Align with international SPC standards.
Source
Select Mandate HA
Select Mandate Function