Últimas noticias
ICH Q1 Draft Guideline & Step 2 Presentation Now Available on the ICH Website
The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products" reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period.
ICH receives the Outstanding Contribution to Health Award at the DIA Europe meeting March in Basel 2025
As ICH celebrates its 35th anniversary in 2025, DIA proudly honors its extraordinary impact on global health.
The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process
The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025.
ICH M11 Updated Technical Specification Step 2 Presentation Now Available on the ICH Website
In follow up to the publication of the ICH M11 Updated Technical Specification (TS) in March 2025, the M11 EWG has also prepared a Step 2 informational presentation.
Further guidance on eSubmissions…
Further guidance on eSubmissions can be found on the EMA website under eSubmission
ICH M13B Draft Guideline & Step 2 Presentation Now Available on the ICH Website
The ICH M13B draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver reached Step 2b of the ICH Process on 13 March 2025 and entered the public consultation period.
ICH M11 Updated Technical Specification Document Now Available on the ICH Website
The ICH M11 updated version of the Technical Specification document, which incorporates comments received during the first public consultation, reached Step 2b of the ICH process in March 2025 and now enters the second round [...]
Act-HIB (Haemophilus type b…
Act-HIB (Haemophilus type b conjugate vaccine (adsorbed))End of procedure: 21/10/2024Date of publication: 05/03/2025
Member: vacantAlternate: Elisa…
Member: vacantAlternate: Elisa SulleiroAgencia Española del Medicamento y Productos SanitariosParque Empresarial Las MercedesEdificio 8C/Campezo 1ES-28022 MADRID
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 & [...]
Questions and answers A…
Questions and answers A question-and-answer document is available for marketing authorisation holders on implementing the Article 5(3) CHMP opinion. It covers the following: Outcome of the Article 5(3) referral and its relation to lessons learned exercise from nitrosamines detected in sartansPrinciples, methodology and [...]