Últimas noticias
ICH Q9(R1) IWG Updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers
The ICH Secretariat is pleased to announce the publication of the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5). The ICH Assembly approved this updated Q9(R1) Annex 1 on 30 October 2024.
ICH M15 draft Guideline presentation available now on the ICH website
The ICH M15 draft Guideline on General Principles for Model-Informed Drug Development reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.
PQKM Task Force RFI
Release of ICH Pharmaceutical Quality Knowledge Management (PQKM) Task Force Request for Information (RFI)
ICH E6(R3) Annex 2 draft Guideline presentation available now on the ICH website
The ICH E6(R3) Annex 2 draft Guideline on Good Clinical Practice reached Step 2b of the ICH Process on 6 November 2024 and entered the public consultation period.
Panzyga and associated names…
Panzyga and associated names (human normal immunoglobin (IVIg))End of procedure: 04/10/2024Date of publication: 25/11/2024
ICH Q13 IWG Video Training Material Modules 1-12 are now available on the ICH Website
The ICH Q13 IWG “Continuous Manufacturing of Drug Substances and Drug Products” Video Training Material Modules 1-12 are now available on the ICH Website.
Updated draft eCTD v4.0 implementation timeline for EU now available
An updated draft timeline for the implementation of eCTD v4.0 in the EU is now available on the eCTD v4.0 page here.
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to the portal made in releases on 14th November 2022 and on 28th November 2022 are now available on the [...]
Press Release: ICH Assembly Meeting, Montréal, Canada, November 2024
The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montréal, Canada in parallel of meetings of 11 Working Groups and 1 Discussion Group, and preceded by [...]
ICH Q9(R1) IWG Updated Training Materials
The ICH Secretariat is pleased to announce the publication of the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM).
ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video now available on the ICH Website
The ICH Secretariat is pleased to announce the publication of ICH E8(R1) General Considerations for Clinical Studies Introductory Training Video.
Best Practice Guides (BPGs) for…
Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, [...]
Guidance is available on the…
Guidance is available on the implementation of the amended Variations Regulation (EU) 2024/1701 for variation applications implemented and submitted from 1 January 2025. This guidance provides instructions on the implementation of the amended Variations Regulation [...]
Q&A – List for the submission of…
Q&A - List for the submission of variations for human medicinal products according to Commission Regulation (EC) 1234/2008 (October 2024) [Track version]
Guidance applicable from 1 January…
Guidance applicable from 1 January 2025 Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition ProcedureChapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for [...]
Added In November 2024 4…
Added In November 2024 4 November NEW - PSUFU SmAR Fluoroquinolones (for systemic and inhalation use)
Fluoroquinolones (for systemic and…
Fluoroquinolones (for systemic and inhalation use)Date of publication: 04/11/2024
Template request for a…
Template request for a recommendation on the classification of an unforeseen variation under Article 5 of Commission Regulation (EC) No 1234/2008 (October 2024) [Track version]
Template Letter of Intent for the…
Template Letter of Intent for the submission of a type IA super-grouped procedure to the reference authority according to Article 7a of Commission Regulation (EC) No 1234/2008 (October 2024) [Track version]
Template Cover letter for the…
Template Cover letter for the submission of variation applications in the MRP (October 2024) [Track version]