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.