- Sep 21
- 2 min
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
- Sep 15
- 2 min
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
- Jul 20
- 2 min
EMA Guidance: EudraVigilance Registration Manual
- Jun 15
- 2 min
EMA Guidance: Proposed Amendments - Variations Categories and Procedures
- Jun 5
- 2 min
EMA Guidance: Procedural Advice on Paediatric Applications
- Jun 5
- 2 min
EMA Guidance: IRIS Guide for Applicants
- May 18
- 2 min
EMA Guidance: EudraVigilance Registration Documents
- Apr 27
- 2 min
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
- Apr 16
- 2 min
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
- Apr 13
- 2 min
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
- Mar 25
- 2 min
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- Mar 2
- 2 min
EMA: QRD updation and Product-Information Templates Updation
- Feb 17
- 2 min
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
- Jan 22
- 2 min
EMA Guidance: Applying for Orphan Designation, IRIS Guide & Orphan Des Procedural Guidance & Forms
- Oct 21, 2023
- 2 min
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
- Oct 14, 2023
- 1 min
EMA Guidance: Post-Authorisation Procedural Advice for Users of the Centralised Procedure
- Oct 10, 2023
- 2 min
EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants
- Oct 2, 2023
- 2 min
EC Q&A Guidance: Questions & Answers: Clinical Trials Regulation
- Oct 2, 2023
- 1 min
EMA Guidance: Pre-Authorisation Procedural Advice for Users of the Centralised Procedure
- Jul 15, 2023
- 1 min
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information