EDQM to assess packaging information as part of certification procedure
This article was originally published in SRA
Executive Summary
The European Directorate for the Quality of Medicines and Healthcare says that packaging information that active substance manufacturers submit in their applications for a certificate of suitability (CEP) will now be assessed during the certification procedure to avoid re-assessment at the marketing authorisation application level1.
You may also be interested in...
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.