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).[…]
Κοινή Κλινική Αξιολόγηση για Γονιδιακές Θεραπείες: Στο Πεδίο από την πρώτη Μέρα
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[…]
Κοινή Κλινική Αξιολόγηση για την Σπάνια Ασθένεια Θεραπείες: Προετοιμασία για το 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 και την Οδηγία για τα Ψευδεπίγραφα Φάρμακα: Κρατώντας την Αλυσίδα Εφοδιασμού Ασφαλής
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[…]