Member: Stavroula…
Member: Stavroula MamouchaAlternate: Eleni Katsomiti National Organization for MedicinesRegistration DivisionMesogion Avenue 284HolargosGR-15562 ATHENS
CMDH PRESS RELEASES 2025
Report from the meeting held on 28-29 January 2025
Pamorelin LA 22.5 mg (triptorelin…
Pamorelin LA 22.5 mg (triptorelin pamoate)End of procedure: 04/12/2024Date of publication: 06/02/2025
Member: Natasa KizaAlternate:…
Member: Natasa KizaAlternate: Maria Eleni Avraamidou Ministry of HealthPharmaceutical Services7 Larnacos AvenueCY-1475 NICOSIA
Updated eAF 1.27.0.0 Human Variation form
Human Variation eAF form - parallel procedures section (further variation regulation update)
Meeting 28-30 January 2025:…
Meeting 28-30 January 2025: Agenda
The ICH E6(R3) Introductory Training Presentation is now available on the ICH website
Following the adoption of the E6(R3) Guideline on 6 January 2025, a Step 4 Introductory Training Presentation has been developed by the E6(R3) Expert Working Group.
The ICH E6(R3) Guideline reaches Step 4 of the ICH Process
The ICH E6(R3) “Good Clinical Practice” Guideline reached Step 4 of the ICH Process on 6 January 2025.
European Medicines Regulatory…
European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) An implementation plan agreed in February 2021 sets out how the European medicines regulatory network, together with the European Directorate for the Quality of Medicines & HealthCare (EDQM), will be implementing the outcome of the Art. 5(3) referral. This includes specific measures that the network will take if nitrosamines are [...]