- Sep 4, 2022
- 1 min
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan
- Sep 1, 2022
- 1 min
EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections
- Aug 25, 2022
- 1 min
EMA: Updated EudraVigilance Registration Manual
- Aug 24, 2022
- 1 min
Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment
- Aug 12, 2022
- 1 min
Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023
- Jul 31, 2022
- 1 min
EMA updated Guidance: IDMP Products Management Services - Implementation Guide
- Jul 26, 2022
- 1 min
EMA Guidance: Prevention of Medicine Shortages in the EU
- Jul 26, 2022
- 1 min
EMA: Plan for Digital Hub for the European Medicines Regulatory Network
- Jun 7, 2022
- 1 min
EMA- New Guidance on Complex Clinical Trials
- May 26, 2022
- 1 min
EMA - Guideline on Treatment of Bacterial Infections
- May 17, 2022
- 1 min
EMA's IRIS Guide for Applicants - On How to Create & Submit Scientific Applications
- Mar 24, 2022
- 1 min
EMA Guidance on Post-Authorisation Procedural Advice for CAP users & EudraVigilance Reg. Manual
- Mar 24, 2022
- 2 min
EMA Guidance on GVP for PPP & Parallel EMA/EUnetHTA 21 Consultation
- Mar 3, 2022
- 1 min
EU Guidelines for Good Manufacturing Practice for Medicinal Products
- Mar 3, 2022
- 1 min
EU Common Standard for electronic Pproduct Information
- Jan 16, 2022
- 1 min
EMA Guidance for Applicants seeking Scientific Advice and Protocol Assistance
- Aug 25, 2021
- 1 min
MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging
- Aug 6, 2021
- 1 min
MDCG Guidance on UDI Integration -European Comission
- Jul 14, 2021
- 1 min
MDCG 2021-14 - Explanatory note on IVDR codes - European Commission
- Jul 1, 2021
- 1 min
Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA