EMA has published updated GMP Q&As on with two new questions dealing with third party audits. QPs should provide a written final assessment and approval of third-party audit reports.
The EMA has published a new version of the '3-year work plan for the Inspectors Working Group' for the period January 2025 to December 2027. This includes planned changes to the EU GMP guidelines.
The joint Q&A of CMDh and CMDv on the QP Declaration has been updated with the deletion of a part of an answer regarding changes to a Marketing Authorisation.
After inadequate root cause analyses were repeatedly the subject of FDA Warning Letters, another one was published on this topic. This time for a global company with a site in the USA.
The European Shortages Monitoring Platform (ESMP) started with the full scope of functionalities. All MAHs are obliged to only use this platform to report data on medicine shortages and availability issues.
The European Medicines Agency (EMA) has published a question and answer on the subject of documentation of the traceability of the supply chain of active substances and the medicinal product.
An updated glossary of terms and definitions has been compiled and published by the Council for International Organizations of Medical Sciences (CIOMS) from across ICH Guidelines.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published new guidance for pharmaceutical manufacturers and wholesalers in order to implement the arrangements of the Windsor Framework for human medicines. This will further widen the gap between the EU and the UK.
Technical Interpretation 17 'Responsible Person: requirements' has been updated with some retroactively applicable requirements. This concerns, among other things, the language skills of the RP.
