GMP News Drug Safety/Pharmacovigilance

The European Commission published an updated Version 6.3 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation. The revised version includes a new Annex with information on where sponsors can find national requirements.

The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.

The FDA published a guidance on the format and content of a risk evaluation and mitigation strategy (REMS) document for prescription drug products including a separate guide that contains a REMS Document Template.

The European Medicines Agency has published pre-submission checklists for certain procedure types. In particular the Validation Checklist for Type II (non)clinical variations has now been updated.

The EMA published the revised Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA. By this revision only the GCP section of the document has been amended. Amongst others it has been clarified that the reporting inspector should be contacted prior to submitting any documents.

The EMA started a pilot to assess whether using raw data can help speed up and improve the medicine-evaluation process. Read more about EMA´s Proof-of-Concept Pilot.

The FDA published a revised draft guidance on frequently asked questions about the agency´s regulation of expanded access to investigational medicinal products. But, what exactly is expanded access?