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.
A recent EU Statement of Non-Compliance with GMP attests an Indian pharmaceutical company that it does not meet GMP requirements. The problem was that critical medicinal products could have been potentially affected.
EMA has published a new version of the "3-year work plan for the Inspectors Working Group" for the period January 2024 to December 2026. It also includes some updated timeframes for the revision of GMP requirements.
As previously reported, China has revised its counter-espionage law. The issue is currently attracting increasing international attention and has now also been taken up by the Financial Times. Several rejections of inspections and one arrest have already been reported.
