Report of 2021 Implementation Survey available now on the ICH website
Monitoring the progress of international harmonisation and coordinating efforts in this regard is an important ICH focus.
The ICH Q13 Step 2 presentation available now on the ICH website
Further to the ICH Q13 draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH Q13 EWG has been finalised.
DADI Project update now available
DADI project update is now available. This update includes a timeline for the first forms to be released, a list of features of the human variation form and an updated questions & answers document.
Updated release schedule for eAF now available Call for volunteers for eAF v1.25.0.0 (reflecting the updated Medical Devices regulation) Updated technical documents for eAF v1.25.0.0 now available
An updated release schedule for the electronic Application Forms (eAF) is now available. The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with a short 1-month transitional period and mandatory use from 1st of November 2021. The release v1.25.0.0 will provide a major change into [...]
Call for volunteers for eAF v1.25.0.0 (reflecting the updated Medical Devices regulation)
The version 1.25.0.0 of the electronic Application Forms (eAFs) is planned for release at the end of September 2021 with short 1-month transitional period and mandatory use from 1st of November 2021. The release v1.25.0.0 will provide a major change into the section 2.2.4 (Medical Device) of the human MAA form as well as adding [...]
The ICH Q13 draft Guideline reaches Step 2 of the ICH process
The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2 of the ICH process on 27 July 2021 and now enters the public consultation period.
Extended deadline for mandatory use of OMS for all CAP submissions
An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) and further information is now available.
Updated draft version of the VNeeS specification v3.0 now available
An updated version (v3.0) of the draft guideline on the specifications for provision of an electronic submission (eSubmission) for veterinary medicinal products (Draft VNeeS guideline) is now available. The updates appearing in track-changes have been implemented mostly to align with the VMP-Regulation (EU) 2019/6. Please note that more updates will be envisaged towards October 2021 [...]
ICH Delighted to Accept 2021 DIA Award for Outstanding Contribution to Health
At DIA’s Global Annual Meeting on 28 June, 2021, DIA announced that it was awarding ICH the 2021 Award for Outstanding Contribution to Health.
Mandatory use of OMS in eAF for all submissions to EMA
The EMA would like to inform applicants and Marketing Authorisation Holders (MAHs) that as part of the development of the Substance, Product, Organisation and Referential (SPOR) data management services, and in anticipation to the upcoming Digital Application Dataset Integration (DADI) project, the registration in Organisation Management Service (OMS) will become mandatory from the 1st of [...]