Latest Comments
Biosimilars in 2026: EMA Moves Away from the Comparative Efficacy Study
The EMA no longer expects comparative efficacy studies for well-characterised biosimilars. What the tailored clinical approach means for developers.
Choosing Your Route to Market: EU Marketing Authorisation Procedures Explained
For any company bringing a medicine to Europe, one of the earliest and most consequential decisions is procedural rather than scientific: which marketing authorisation route[…]
ATMPs: The Regulatory Path for Advanced Therapies
Cell and gene therapies are among the most promising — and most complex — medicines in development. Advanced therapy medicinal products follow a dedicated regulatory[…]
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 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,[…]
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[…]
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).[…]
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[…]