Pharmaceutical industry

As of April 2025, EMA will no longer send notifications to marketing authorisation holders (MAHs) of centrally authorised generics, hybrids or biosimilars of centrally authorised reference medicines when its product information has been updated. Instead, EMA will start publishing this product information as Word documents with visible track changes, in addition to clean PDFs. These documents will be available in all EU languages on medicine pages on this website. MAHs will need to download these documents to submit the relevant type IB variation within two months. More information is available in section 4.2 on the Generic and hybrid applications webpage.

EMA has updated its guidance (‘questions and answers’) on the implementation of EU regulations on medical devices and in vitro diagnostic medical devices. This addresses situations when a declaration of conformity is not available for class I integral medical devices (excluding Is – sterile condition and Im – measuring function devices). When this happens, marketing authorisation holders can submit a statement of compliance with the relevant general safety and performance requirements (GSPRs) to meet requirements of article 117 of the Medical Device Regulation.

As of 29 January 2025, marketing authorisation holders (MAHs) and national competent authorities (NCAs) can now also use this platform to submit data on supply and demand of medicines during crisis and preparedness situations. This launch is ahead of the legal deadline of 2 February 2025. In November 2024, EMA released the first functionality of the platform for MAHs to report shortages of centrally authorised products. More information is available on this website, including training materials and recordings of previous training events.

The report outlines the performance of the ePI authoring tool, guidance and processes during a dedicated pilot. It includes recommendations on how to embed ePIs in regulatory procedures of authorities across Europe. During the pilot, pharmaceutical companies created and managed ePIs, following the related EU ePI Common Standard. Four national authorities participated. The pilot ran between July 2023 and August 2024.

As of January 2025, all submissions for EMA-led post-authorisation procedures initiated from 20 December 2024 via the current systems will be managed in the IRIS online platform. This concerns all centrally and nationally authorised products. Marketing authorisation holders for these procedures should have an EMA account and industry user role. Periodic safety update report procedures will transition to IRIS from 6 February 2025. More information is available in EMA’s submission guidance on regulatory procedure management for the product lifecycle management.

Guidance on the implementation of the amended Variations Regulation is available for marketing authorisation holders of human medicines. The Regulation will be applicable as of 1 January 2025. It includes new and updated processes on the mandatory annual update for Type IA variations and its exemptions, on the (super-) grouping of Type IA variations, on the mandatory and voluntary worksharing procedure and on recommendation for unforeseen variations.

This reflection paper provides considerations for medicine developers and applicants on the safe and effective use of AI and machine learning throughout the medicine lifecycle. The document covers stages from medicine development to the post-authorisation. CHMP and CVMP adopted this reflection paper in September 2024.