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 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.

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.

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 [...]

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.

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 [...]

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 replacing the PDF format eAFs, the registration in Organisation Management Service (OMS) will become [...]

CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product (October 2023) [Tracked version]  - Annex 2 - Applicant's declaration template  (January 2023)

Request for RMS in a Decentralised Procedure, medicinal products for human use   Common request form (June 2023)

Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)