Regulatory News

QP Declaration: New Q&As published

The European Medicines Agency (EMA) has published a Q&A document on how third-party audits should be reflected in Part C of the QP Declaration.

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EMA: QPs must provide a written final Assessment and Approval of Third-Party Audit Reports

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.

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EMA's Plans for the next three Years

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.

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Q&A Document on QP Declaration updated

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.

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Warning Letter for Big Pharma Company: Root Cause Analysis a Topic

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.

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European Shortages Monitoring Platform (ESMP) goes live

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.

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Windsor Framework Explainer Document published

The UK MHRA has published an "Explainer for Industry" on the Windsor Framework. It explains the main changes and what companies need to do to prepare.

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EMA Comments on the Role of the QP in Supply Chain Traceability

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.

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Glossary of ICH Terms and Definitions published

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.

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MHRA: New Rules for Manufacturers and Wholesalers after Brexit

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.

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