ISO 27001 and Data Integrity: Information Security Risks in a GxP Environment
Information security has quietly become a GMP concern. As pharmaceutical operations move to cloud platforms, connected instruments and AI-assisted systems, the confidentiality and integrity of[…]
The EU Medical Technology Framework: A Compliance Roadmap for 2026 and Beyond
The European Union’s medical technology rulebook — the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) — is the most demanding device[…]
Biosimilars in Europe: Interchangeability and the New Tailored Clinical Approach
By 2026 the European biosimilar framework has matured from cautious, case-by-case review into one of the most confident regulatory systems in the world — and[…]
The In Vitro Diagnostic Regulation: Transition Deadlines and the Path to Compliance
The In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746, has applied since 26 May 2022, replacing the long-standing In Vitro Diagnostic Directive (98/79/EC).[…]
Joint Clinical Assessment for Gene Therapies: In Scope from Day One
Unlike most medicines, gene therapies have been subject to the EU Joint Clinical Assessment (JCA) since it began on 12 January 2025. As advanced therapy[…]
Joint Clinical Assessment for Rare Disease Therapies: Preparing for 2028
The EU Joint Clinical Assessment (JCA) will extend to orphan medicines from January 2028, drawing rare disease therapies into a single, EU-wide clinical assessment. For[…]
Serialisation and the Falsified Medicines Directive: Keeping the Supply Chain Safe
Since February 2019, almost every prescription medicine pack in the EU has carried two safety features — a unique 2D barcode and an anti-tampering device[…]
The Qualified Person and Batch Release: The Last Line of Defence
No medicinal product can be placed on the EU market until a Qualified Person (QP) has certified the batch. It is one of the most[…]
Paediatric Investigation Plans: Planning for Children from the Start
For most new medicines in the EU, studying the product in children is not optional. Under the Paediatric Regulation, a paediatric investigation plan (PIP) must[…]
Advanced Therapy Medicinal Products: Navigating the EU Regulatory Pathway
Advanced therapy medicinal products (ATMPs) — gene therapies, somatic-cell therapies and tissue-engineered products — are among the most complex products to bring to the European[…]