Patients across Great Britain will have continued access to medical devices and in vitro diagnostic devices (IVDs) already approved for the EU market.   Patients across Great Britain will continue to have access to the medical devices and in vitro diagnostic...

The content of section 5.1 (“Pharmacodynamic properties”) of the Summary of Product Characteristics (SmPC) is proposed by the applicant or marketing authorisation holder and it is assessed by the rapporteur/s. The final content is discussed by the Committee for Human...

The objective of this workshop was therefore to gather structured, experience-based input from industry on the control, governance, and mitigation measures applied throughout the AI system lifecycle, with particular emphasis on the application of ICH Q9 quality risk...

Guideline published on: 24/09/2026 Good Manufacturing Practice (GMP) provides the foundation for ensuring that medicinal products are consistently manufactured and controlled according to appropriate quality standards.