- Jul 4, 2023
- 2 min
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
- Jul 3, 2023
- 1 min
EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
- Jun 27, 2023
- 1 min
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
- Jun 17, 2023
- 1 min
EMA Guidance: Paediatric Submissions Via Syncplicity Web Client
- May 18, 2023
- 1 min
EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages
- May 7, 2023
- 2 min
EMA Interim Guidance: How to Approach the "PPD and CCI" while using CTIS
- Apr 29, 2023
- 1 min
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
- Apr 23, 2023
- 1 min
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
- Mar 11, 2023
- 1 min
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
- Feb 27, 2023
- 1 min
EMA Procedural Advice: Recommendations on Unforeseen Variations
- Feb 25, 2023
- 1 min
Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators
- Feb 14, 2023
- 1 min
EMA Checklist: Updated Validation checklist for Type II quality variations
- Jan 16, 2023
- 2 min
EMA Guidance: Format & Validity Features of e-Certificates and How to Fll the Application Form
- Nov 12, 2022
- 1 min
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
- Nov 4, 2022
- 1 min
EMA Guidance: Anonymisation of PPD & CCI - Preparation of Risk Management Plans (RMP)
- Nov 4, 2022
- 1 min
EMA Guidance: Pre & Post-Authorisation Procedural Advice for Users of the Centralised Procedure
- Oct 17, 2022
- 1 min
EMA Guidance: Scientific Advice and Protocol Assistance
- Oct 13, 2022
- 1 min
EMA Guidance: How to Fill the Application Form for Centralised Type IA and IB Variations
- Sep 30, 2022
- 2 min
EMA Guidance: Checking process of Mock-ups & Specimens of Outer/Immediate Labelling & PI -CP
- Sep 4, 2022
- 1 min
IRIS Updated Guide: How to Create & Submit Scientific Applications & Accelerating Clin. Trials Plan