In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the eSubmission website.

In light of an ongoing application study at the European Medicines Agency, we are gathering feedback on the PSUR Repository.

An updated version of the eSubmission Gateway XML delivery file user interface will be available starting with 1 December 2023, 18:00 CET. This update introduces in the delivery file for Human submissions the option to choose "Re-examination" submission unit for various submission types. Use this unit for requesting re-examination of opinion for MAA, extension, Type [...]

Added in December 11 December NEW - 12-14 December 2023 CMDh agenda

An updated version 1.26.0.0 of the Variation and Renewal (both Human and Veterinary) eAF is available starting with 28 November 2023, 18:00 CET.

The Human Harmonisation Group has analysed the change requests received upon opening the eCTD EU Module 1 Specification for review and is now publishing the draft documents for public consultation.

EMA is pleased to announce a public webinar (event page on EMA website) for medicines developers and regulators eager to gain deeper insights into what the Agency's Product Lifecycle Management (PLM) value stream is working on and its goals. The event will take place on 30 November, 14:00 - 16:00 (CET).

ICH is launching a request for proposal for technical/regulatory writing services to support the drafting activities associated with ICH guideline development in support of ICH EWG Member and Observer representatives.

Montelukast Date of publication: 22/11/2023

An updated version of the PLM Portal eAF FHIR XML Release notes reflecting the implementation of FHIR XML 1.2.0 in the PLM Portal eAF (to be released to production on 21 November 2023) are now available on PLM Portal Forum.