INTELLIGENCE OVERVIEW The European Medicines Agency (EMA) has issued a Validation Checklist for Type II (non)clinical variations, defining the mandatory documentation required for successful validation of post-authorisation variation applications. Date…
INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Sanofi – New medicinal productIndication: Chronic graft-versus-host disease (cGVHD)Procedure: CentralisedStatus: Positive CHMP opinion Date of Publication: 30-Jan-2026 The EMA’s Committee for Medicinal Products…
Agency/Company: European Medicines AgencyCountry: European UnionDate: 22-Jan-2026 Intelligence Overview: The European Medicines Agency’s guidance on the Product Management Service (PMS) highlights a major step forward in implementing ISO IDMP standards…