EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
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 - Guideline on Treatment of Bacterial Infections
Q&A Guidance on Unique Device Identification system - Medical Device Coordination Group
EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)
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
Guidance for Clinical Trials Conducted under the Clinical Trials Regulation (CTR) in Ireland
EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA
Updated Guideline on Registry-Based Studies (EMA)