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Paediatric Investigation Plans: Planning for the Youngest Patients
For most new medicines, developing for adults is only part of the obligation. The Paediatric Investigation Plan determines what a company must do for children[…]
The Clinical Trials Regulation: Life After the Transition
Since the start of 2025, there is only one way to run a clinical trial in the EU. The Clinical Trials Regulation and its portal,[…]
The IVDR: Extended Deadlines, but No Room for Complacency
The In Vitro Diagnostic Regulation reshaped how diagnostics reach the EU market — and while transition deadlines have been extended, the conditions attached to them[…]
The Clinical Trials Regulation and CTIS: One Portal, One Assessment
The Clinical Trials Regulation (EU) No 536/2014 has reshaped how trials are authorised across Europe. Since the three-year transition period closed on 31 January 2025,[…]
Nitrosamine Impurities: Managing a Risk That Has Not Gone Away
The regulatory deadlines for nitrosamine impurities have passed, but the obligation has not. What began in 2018 as an urgent response to contaminated sartans has[…]
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[…]