China: ICH M11 Electronic Structured Clinical Protocol Guidelines Open for Public Consultation
Advancing Clinical Trial Protocol Standardization & Global Regulatory Harmonization Comments Accepted Until July 12, 2026
NMPA | Pharmaceuticals | Regulatory AffairsINVIMA ASS-RSA-IN56: Updated Guidelines for User Inserts, Prescribing Information (IPP), and Safety & Efficacy Modification Formats
For preparing and harmonizing patient package inserts and prescribing information, and requirements/formats for submitting safety and efficacy modifications to the marketing authorization of medicines and biological products.
INVIMA | Pharmaceuticals | Regulatory AffairsINVIMA ASS-RSA-FM080: Updated Evaluation Format for New Association, Pharmaceutical Form and Concentration of Synthetic Medicines
Regulatory submission process for pharmaceutical products, including applicant information, product details, classification, and required studies.
INVIMA | Pharmaceuticals | Regulatory AffairsINVIMA IVC-VIG-GU003: Updated Pharmacovigilance Guide for Periodic Safety Reports (PSUR)
Guidance establishing standardized requirements for preparing and submitting Periodic Safety Reports (PSUR) for marketed pharmaceutical products.
INVIMA | Pharmaceuticals | Regulatory AffairsINVIMA ASS-RSA-FM081: Updated Format for Pharmacological Evaluation of New Synthetic Medicine Molecules
Regulatory form and requirements for submitting a pharmacological evaluation dossier for a new synthetic medicine molecule to INVIMA, including applicant and product information, pharmacological data, supporting studies, risk management plan, and notification conditions.
INVIMA | Pharmaceuticals | Regulatory Affairs
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