Swissmedic Updates Formal Requirements Guidance Document to Version 22.0
Swissmedic has updated its Formal requirements guidance document to version 22.0, setting out administrative and submission requirements for applications, variations, medicinal product information, packaging, combination products, DMF/ASMF and special product types.
Swissmedic Updates Technical Interpretation on Container-Specific Identity Guarantee of Starting Materials
Swissmedic has published version 6.0 of its technical interpretation on the container-specific guarantee of starting material identity, defining requirements for suppliers, GMP controls, labelling, certificates of analysis and inspections.
COMBINE Programme Advances to Second Phase of Coordinated Assessment Pilot for Combined Clinical Trials
The European Commission and EU Member States have launched the second phase of the COMBINE pilot programme, expanding coordinated assessment to additional types of combined clinical trials involving medicines and medical devices.
EMA Updates Guidance on Electronic Submission of Medicinal Product Data under PMS and ISO IDMP
The EMA has published version 3.6 of its guidance on the implementation of ISO IDMP standards through the Product Management Services (PMS), introducing updates related to data submission, data enrichment, and requirements applicable to marketing authorisation holders.
MHRA Publishes Updated Guide on Defective Medicinal Products
The MHRA has published its February 2026 Guide on Defective Medicinal Products. Learn what UK manufacturers and marketing authorisation holders must do regarding defect reporting, recalls, and DMRC obligations.