Pharmaceutical industry
On this page, you will find information on the Agency’s activities that are most relevant to pharmaceutical industry, including news, and events.
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Featured information for the pharmaceutical industry
New PMS data submission deadlines for marketing authorisation holders
In September 2025, EMA extended the deadlines for key data submission to its Product Management Service (PMS). This decision addresses the challenges that marketing authorisation holders (MAHs) raised. For the enrichment of structured manufacturer data and pack size for non-centrally authorised products (non-CAPs) part of the Union list of critical medicines, the new deadline is June 2026. For the enrichment of pack sizes for all other non-CAPs and structured pack sizes, the deadline is June 2027. For structured manufacturer data submission, the deadlines remains December 2026.
European Commission publishes new Variation Guidelines
The European Commission has published the new Variation Guidelines which will apply as of January 2026. These guidelines aim to facilitate quicker processing of variations and support the implementation of the revised Variation Regulation, which came into force on 1 January 2025. To assist marketing authorisation holders implementing the new variation framework, EMA has been publishing guidance and it will continue doing so by the end of 2025.
Report on EMA-HMA medicine repurposing pilot
A report is available on a pilot that provided tailored scientific advice to not-for-profit organisations and academics on repurposing authorised medicines for new indications. The report contains findings and recommendations from the pilot. EMA and Heads of Medicines Agencies (HMA) carried out this pilot between 2021 and 2024.
EMA-CMDh report on response to nitrosamine impurities
A report outlining the European medicines regulatory network’s response to nitrosamine impurities in human medicines is available. The report summarises the milestones since the discovery of nitrosamine impurities in 2018. EMA and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) produced this report jointly.
Process changes for centrally authorised generic, hybrid or biosimilar reference medicines
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.
Medical devices and in vitro diagnostics: Update on compliance with requirements for class I integral medical devices
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.
Transition of post-authorisation procedures to IRIS: actions for marketing authorisation holders
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.
EMA publishes reflection paper on use of artificial intelligence (AI)
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.
Latest news
Seven new medicines recommended for approval; another 12 medicines recommended for extension of their therapeutic indications
Anktiva provides an alternative to surgery for patients whose cancer does not respond to treatment with Bacillus Calmette-Guérin
Reform to enhance patient access, strengthen medicine supply security and boost innovation
Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting
Publications of interest
EMA's 2023 annual report
Navigate through the digital report to view interviews, short videos and an interactive timeline of the Agency’s main activities in 2023. Read the traditional PDF version to see additional figures and statistics on EMA's regulatory procedures and activities.
Factsheet: PRIME – Paving the way for promising medicines for patients
Check our factsheet for an at-a-glance overview of EMA's PRIME scheme.
Video: Working for every patient in Europe
Watch our short video for a quick and easy explanation of who EMA is and what it does. (video in English, with subtitles in 24 different languages).