EMA’s Latest IDMP/PMS Update Is Really a Data-Governance Issue
EMA updated several Product Management Service/ISO IDMP implementation documents on August 12, including Chapter 3 covering the electronic submission and maintenance of medicinal-product information. For marketing authorization holders, this is less a “new regulation” story than a regulatory-data-governance story. The updated Chapter 3 is Version 3.7. EMA says this version…