News & Trends
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Recentes
- Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 2)
- Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies
- UK National Commission into the Regulation of AI in Healthcare
- EMA Article 57 Q&A Version 1.15 (9 September 2026)
- EMA guidance on Electronic product information (ePI) submission during centralised procedures
- EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Device Regulation (2017/746) – Impact on international registrations. Middle East and Africa focus
- IMDRF Document Implementation Report. 1 September 2026
- EU Regulatory News : IVD Classification Rules – MDCG 2020-16 Rev.5