EUDAMED Release note v 2.18.0

Recentes

• EUDAMED Release note v 2.18.0
• The ICH E2D(R1) Guideline reaches Step 4 of the ICH Process
• The impact of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to address shortages of human and veterinary medicines across Europe
• The European Medicines Agencies Network Data Strategy
• Guidelines on key considerations in issuing recommendations on the classification of active substances as regards their supply (prescription and non-prescription status)
• España aprueba la regulación del cannabis medicinal para uso hospitalario y prescripción por especialistas
• EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements
• ICH E20 draft guideline on adaptive designs in confirmatory clinical trials