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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[…]

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 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 (EU) No 536/2014 has reshaped how trials are authorised across Europe. Since the three-year transition period closed on 31 January 2025,[…]

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[…]

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 European Union’s medical technology rulebook — the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) — is the most demanding device[…]

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 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).[…]

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[…]