The European Medicines Agency (EMA) has published the European Medicines Agencies Network Data Strategy on 3 October 2025, following a public consultation conducted between November and December 2024. The strategy focuses on making more effective use of data hosted by the European medicines regulatory network and aims to ensure data meets high quality standards whilst being appropriately organised, standardised and easily shared among regulators and stakeholders. The document, reference number EMA/128369/2025, is intended to facilitate collaboration and more informed regulatory decision-making across the network. The strategy builds on EMA's existing work in leveraging data including regulatory submissions data, substance and product master data, and real-world data such as electronic health records and patient registry data to support public health decisions in the European Union.

The European Medicines Agency (EMA) has published a concept paper, proposing the establishment of a European Platform for Regulatory Science Research. The Platform aims to accelerate and advance regulatory science research and enhance the quality of research to improve regulatory practices and medicine development. The EMA has launched a consultation on the concept paper, which closes on 18 December 2024. The EMA has launched a consultation on the 2024 update to its Regulatory Science Research Needs (RSRN) initiative, which also closes on 18 December 2024. This consultation seeks input on research priorities to address gaps in regulatory science and improve medicine development and evaluation. The RSRN outlines research needs across four key areas: clinical research improvement, regulatory system evolution, leveraging technologies for specific medicine types, and advancing veterinary medicine regulation.

The European Medicines Agency (EMA) has published details of the new Medicines Shortages Steering Group (MSSG) solidarity mechanism which allows Member States facing a critical medicine shortage to request assistance from other Member States in obtaining medicine stocks. As it is developed as a last resort for Member States after they have exhausted all other possibilities, it can be used in only limited circumstances. The mechanism also compliments actions laid out in the MSSG Toolkit, including recommendations for monitoring supply and demand and guidance on interactions with marketing authorisation holders and manufacturers to increase and redistribute existing stocks and implement regulatory flexibilities.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), acting jointly with the Network Data Steering Group (NDSG), have approved an updated 2026–28 workplan setting out how EU regulators will leverage artificial intelligence (AI) and big data to accelerate and strengthen medicines evaluation and oversight. Adopted in February 2026 and replacing a March 2025 version, the plan establishes a coordinated two-year strategy to enhance data interoperability, expand real-world evidence generation, embed AI across the medicines lifecycle and support implementation of the revised EU pharmaceutical legislation, with the stated objective of improving regulatory decision-making for human and veterinary medicines.

The European Medicines Agency (EMA) has published questions and answers (Q&As) on its collaboration with Health Canada (HC) for Clinical Data Publication (CDP). The Q&As set out a voluntary work-share initiative under which the EMA and HC jointly review and publish clinical data for medicines submitted for marketing authorisation in both jurisdictions, aiming to reduce duplication and align timelines. The document provides guidance for applicants on the work-share process, including eligibility criteria, submission requirements and responsibilities. Participation is limited to initial marketing authorisation applications submitted to both agencies and requires, among other conditions, aligned regulatory timelines and a significant overlap in documentation. The guidance also covers the preparation of redaction proposals, anonymisation reports and final data packages, as well as the handling of commercially confidential information and publication procedures.

The European Medicines Agency (EMA) has released new guidance to support a second pilot of the Simultaneous National Scientific Advice (SNSA), following the initial pilot phase which ran from 2020—2022 which recieved more than 33 requests. The EMA has also published several new resources including a procedure Flowchart, SNSA meeting minutes template for applicants, SNSA final advice report template, an application form to request SNSA and updated guidance for applicants on SNSA Briefing. The second pilot phase will run for a two year period, until 2026.

The European Medicines Agency (EMA) has published a draft addendum to a guideline on vaccine development that encourages collecting clinical trial data on immunocompromised people in certain situations. The Addendum advises that when testing live vaccines, sponsors should delay trials to collect more safety and efficacy data on immunocompetent patients before evaluating them. The EMA acknowledged that studying a vaccine in every subset of immunocompromised patients is not feasible. Instead, it recommended that sponsors identify one or more subgroups of immunocompromised patients who may be enrolled in sufficient numbers for a trial and ensure the data collected can be adequately extrapolated. The Addendum provides guidance on several other factors, such as statistical considerations when conducting the trials and evaluating the data and safety considerations. It does not address issues such as evaluating how common diseases associated with milder forms of immunodeficiencies may predispose patients to certain infections or developing vaccines only for immunocompromised patients or their subgroups

The European Medicines Agency (EMA) has published a concept paper on the clinical evaluation of therapeutic radiopharmaceuticals (tRPs) in oncology. It seeks to identify aspects that are specific for tRPs that need to be addressed in a future guideline, which will complement the Guideline on the clinical evaluation of anticancer medicinal products. The concept paper is now being consulted upon, with a deadline for comments being 31 January 2025. The final guideline is expected to come into operation six months after its publication.

The European Medicines Agency (EMA) has published the data quality framework for European Union medicines regulation, which sets out guidance and recommendations to assess the quality of datasets used in regulatory decision-making to support benefit‑risk decisions. The framework aims to provide a consistent and standardised approach to data quality, support pharmaceutical companies and other stakeholders in selecting data sources for their studies, and ensure trust among patients and healthcare professionals in data‑driven regulatory decision‑making. The framework was co‑produced by EMA, the Heads of Medicines Agencies (HMA) and the Joint Action Towards the European Health Data Space (TEHDAS), with initial focus on real‑world data and adverse drug reactions and includes a dedicated real‑world data chapter first published on 27 March 2026.

The European Medicines Agency (EMA) has published a draft Guideline on the development and manufacture of synthetic peptides which is open for consultation. The aim of the Guideline is to outline the type of information required for the development, manufacture and control of synthetic peptides (existing or new chemical entities) used in a medicinal products. The deadline for response is 30 April 2024.

The European Medicines Agency (EMA) has published its first AI Observatory report and supporting documents on 10 July 2025. The report compiles regulatory experience from across the EU network on the use of artificial intelligence (AI) in the medicine lifecycle, including automation, clinical trial support, and pharmacovigilance. It also includes a horizon scanning analysis of AI opportunities and challenges. The findings will inform EMA’s multi-annual AI workplan and support preparation for the EU AI Act.

The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published their first quarterly report on progress towards the EU’s 2026–30 clinical trial targets, covering activity from January to March 2026. The report found that 19 additional multinational clinical trials were authorised above the historical average, contributing towards the target of 500 extra multinational trials by 2030, while 40.5% of clinical trials recruited participants within 200 days of application submission, against a target of 66% by 2030. During the quarter, 538 clinical trials were authorised and 668 initial applications were submitted, with the number of multinational trial authorisations increasing from 58 in January to 110 in March. The report noted that commercial sponsors were closer to meeting recruitment timeline targets than non-commercial sponsors. It also stated that more than 13,700 clinical trial applications have been submitted since the launch of the Clinical Trials Information System (CTIS) in 2022 and that over 6,425 trials were ongoing in the EU and European Economic Area as of March 2026. The report said the targets support the proposed EU Biotech Act and wider ACT EU initiatives intended to accelerate clinical trial authorisations and strengthen the EU’s position as a location for high-quality clinical research.