EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
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
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EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)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
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)
Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA