INVIMA IVC-VIG-FM70: Updated Format for Submitting Risk Management Plan (PGR) Updates
Formal template specifying requirements and structure for submitting updates to Risk Management Plans (PGR) to INVIMA.
INVIMA | Pharmaceuticals | Regulatory AffairsINVIMA Resolution 2026025611 of May 21, 2026: Contingency Plan for Rationalization and Automation of Sanitary Registration Procedures
Establishes a contingency plan to streamline, automate, and prioritize sanitary registration procedures and related regulatory activities managed by INVIMA's Directorate of Medicines and Biological Products.
INVIMA | Pharmaceuticals | Regulatory AffairsINVIMA ASS-RSA-FM195: Submission of Modifications to Product Labelling Administrative Information (Safety and Efficacy)
The procedures and requirements for submitting modifications related to changes in the administrative information of product labeling, in accordance with Decree 334 of 2022, including necessary approvals and documentation.
INVIMA | Pharmaceuticals | Regulatory AffairsANVISA VigiMed Instruction Manual for Adverse Event Notification in Health Services
The manual provides comprehensive procedural guidance for healthcare services on reporting adverse drug events in the VigiMed system, ensuring adherence to technical and regulatory standards set by ANVISA.
ANVISA | Pharmaceuticals | Regulatory AffairsFDA Final Guidance: Certain Postapproval Requirements and Resources for ANDAs
FDA finalised guidance on 4 June 2026 clarifying the postapproval obligations for Abbreviated New Drug Application (ANDA) holders — covering labelling, chemistry, manufacturing and controls (CMC) changes, and compliance commitments after generic drug approval.
FDA | Pharmaceuticals | Regulatory Affairs
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