GMP News Drug Safety/Pharmacovigilance

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios. In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed.

EMA's Query Management Working Group prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation.

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection. The Q&A document has been created to provide guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS.

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.