The Assembly of the International Council for Harmonisation (ICH) met in-person on the 15 - 16 November 2022, in Incheon, Republic of Korea in parallel of meetings of ten Working Groups, and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
Euvax B (Vaccinum hepatitidis B (ADNr)) End of procedure: 12/10/2022 Date of publication: 16/11/2022
Decapeptyl / Diphereline /Arvekap (triptorelin) PT/W/0003/pdWS/001 End of procedure: 04/07/2013 Date of publication: 16/11/2022 PT/W/0003/pdWS/002 End of procedure: 30/06/2023 Date of publication: 03/04/2024
EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) is now available on the new Product Lifecycle Management (PLM) Portal. This is a big, first milestone in the ongoing journey to improve the eAFs and related processes. EMA has been collaborating with the UNICOM consortium to [...]
An updated version of the PLM Portal (eAF) guide to registration is now available on PLM Portal eAF (DADI). The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. Most of these steps are independent from the PLM Portal eAF and correspond to those [...]
The ICH E19 Guideline on A Selective Approach to Safety Data Collection in Specific Late-stage Pre-approval or Post-approval Clinical Trials reached Step 4 of the ICH Process in September 2022.
The ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), Technical Specification and Template reached Step 2 of the ICH process on 27 September 2022.
Iohexol Date of publication: 25/10/2022
An updated version 1.26.0.0 of the human variation eAFs is now available here. A single change has been implemented to emphasize the mandatory use of OMS for centralised procedure by updating the Declaration label in the Proposed section. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is [...]
The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022.