ICMRA Summit 2025: EMA concludes its two mandates as chair
Submitted by Anonymous (not verified) on 24 October 2025 - 13:28
ICMRA Summit 2025: EMA concludes its two mandates as chair
Minutes of the PRAC meeting 1-4 September 2025
Submitted by Anonymous (not verified) on 24 October 2025 - 13:04
Minutes of the PRAC meeting 1-4 September 2025
Committee for Advanced Therapies (CAT) workshop on gene editing, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 September 2025, 10:00 (CEST) to 16 September 2025, 17:00 (CEST)
Submitted by Anonymous (not verified) on 24 October 2025 - 12:30
Committee for Advanced Therapies (CAT) workshop on gene editing, Online, European Medicines Agency, Amsterdam, the Netherlands, from 16 September 2025, 10:00 (CEST) to 16 September 2025, 17:00 (CEST)
Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10), Date of authorisation: 13/01/2025, Revision: 2, Status: Authorised
Submitted by Anonymous (not verified) on 24 October 2025 - 11:00
Human medicines European public assessment report (EPAR): Siiltibcy, Mycobacterium tuberculosis derived antigens (rdESAT-6 / rCFP-10), Date of authorisation: 13/01/2025, Revision: 2, Status: Authorised
Quality aspects of phage therapy medicinal products
Submitted by Anonymous (not verified) on 24 October 2025 - 9:20
Quality aspects of phage therapy medicinal products
Opinions and letters of support on the qualification of novel methodologies for medicine development
Submitted by Anonymous (not verified) on 24 October 2025 - 9:05
Opinions and letters of support on the qualification of novel methodologies for medicine development
Annex IV - Discussion meeting with applicant - molecule-independent device bridging approach (MIDBA)
Submitted by Anonymous (not verified) on 24 October 2025 - 9:04
Annex IV - Discussion meeting with applicant - molecule-independent device bridging approach (MIDBA)
Annex I - Briefing document - molecule-independent device bridging approach (MIDBA)
Submitted by Anonymous (not verified) on 24 October 2025 - 9:00
Annex I - Briefing document - molecule-independent device bridging approach (MIDBA)
Annex III - Written responses to list of issues - molecule-independent device bridging approach (MIDBA)
Submitted by Anonymous (not verified) on 24 October 2025 - 9:00
Annex III - Written responses to list of issues - molecule-independent device bridging approach (MIDBA)
Annex II - Initial Qualification Opinion List of Issues - molecule-independent device bridging approach (MIDBA)
Submitted by Anonymous (not verified) on 24 October 2025 - 9:00
Annex II - Initial Qualification Opinion List of Issues - molecule-independent device bridging approach (MIDBA)