IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
EMA: Updated EudraVigilance Registration Manual
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
EMA Guidance: Prevention of Medicine Shortages in the EU
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
EMA- New Guidance on Complex Clinical Trials
EMA - Guideline on Treatment of Bacterial Infections
EMA's IRIS Guide for Applicants - On How to Create & Submit Scientific Applications
EMA Guidance on Post-Authorisation Procedural Advice for CAP users & EudraVigilance Reg. Manual
EMA Guidance on GVP for PPP & Parallel EMA/EUnetHTA 21 Consultation
EU Guidelines for Good Manufacturing Practice for Medicinal Products
EU Common Standard for electronic Pproduct Information
EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging
MDCG Guidance on UDI Integration -European Comission
MDCG 2021-14 - Explanatory note on IVDR codes - European Commission
Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA