The European Medicines Agency has published its sponsor frequently asked questions on the Clinical Trial Information System (CTIS). It explains how sponsors should apply the Clinical Trials Regulation across the clinical trial lifecycle, including sponsor access and user roles, organisation and product registration and trial classification. It also covers application submission, assessment processes, requests for information, timelines and modifications. The document also outlines sponsor obligations during trial conduct, including notifications and safety reporting, as well as trial closure and results submission. It further addresses the protection of commercially confidential information and signposts CTIS training, support and governance resources.

The European Medicines Agency (EMA) has published three-year work plans for five working groups: Biosimilars, Biologics, joint CHMP/CVMP Quality, Non-clinical domain and Synthetic Peptides, covering the period 2026–2028. The plans outline strategic and tactical goals including advancing regulatory science, harmonising EU and international guidelines, and supporting innovation in medicines development. Key priorities include guidance on biosimilar comparability and tailored clinical approaches, quality aspects for biologicals and RNA vaccines, risk-based strategies for chemical and biological active substances, integration of new approach methodologies (NAMs) and replacement, reduction and refinement (3Rs) principles in non-clinical testing, and publication of a guideline on synthetic peptides addressing manufacturing, characterisation and control requirements.

The European Medicines Agency (EMA) has published the updated ICH E6(R3) guideline for good clinical practice, which will take effect on 23 July 2025. This updated guideline introduces a new structure comprising overarching principles and objectives document, Annex 1 for interventional trials, and Annex 2 for non-traditional interventional trials. ICH E6(R3) incorporates innovative provisions designed to apply across various trial types and settings, promoting a risk-based, proportionate approach to conducting clinical trials. Annex 1 is intended to provide guidance on applying the overarching principles to clinical trials. ​The overarching principles and Annex 1 have been adopted by ICH and CHMP and will take effect in July 2025.  Annex 2, which addresses pragmatic and decentralised clinical trials, as well as those incorporating real-world data, is expected to be finalised later in 2025. The current ICH E6(R2) guideline in effect until 22 July 2025, enabling stakeholders to transition to the new standards.

The European Medicines Agency (EMA) has published the final version of revision 3 of Module XVI on risk minimisation measures, and its Addendum II, of the guideline on good pharmacovigilance practices (GVP). This revision takes into account the comments received from the public consultation which ran between February and April 2021, recent experiences and research on risk minimisation measures, as well as advances in the field. As a result of new terminology used in Module XVI and the coming into force of Regulation (EU) 536/2014 (the EU Clinical Trials Regulation), revision 5 of Annex I of the GVP, which contains the definitions, has also been published.

The European Medicines Agency (EMA) has released three-year work plans for its Oncology Working Party (ONCWP) and Infectious Diseases Working Party (IDWP), detailing strategic, tactical, and operational goals from January 2025 to December 2027. These plans aim to enhance guideline development, training, and stakeholder engagement in oncology and infectious diseases, supporting the EMA's broader regulatory strategy.

The European Medicines Agency (EMA) has updated its website to include an FAQs document to support the implementation of ICH M10 on bioanalytical method validation and has released two documents providing the comments and summary of comments received in the public consultation that concluded on 31 January 2024.

The European Medicines Agency (EMA) has released the updated November 2023 Questions & Answers (Q&As) on the EU framework for (traditional) herbal medicinal products and from a 'non-European' tradition.

The European Medicines Agency (EMA) has published a data access policy for the upcoming European Shortages Monitoring Platform (ESMP) on March 10, 2025, along with updates to related guidance materials. The policy outlines principles for accessing ESMP data in line with Article 13(6)(f) of Regulation (EU) 2022/123 (Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices), which strengthens the EMA’s role in managing medicine and medical device shortages. It also establishes a tiered framework for controlled public access to shortage information, addressing different stakeholder needs and data sensitivity.

The European Medicines Agency (EMA) has released the outcome of a series of workshops it held between Health Technology Assessment bodies (HTAbs) and regulators aimed at the assessment and resolution of challenges each decision maker faces as a result of current uncertainties and approaches to evidence generation when seeking assessment of therapies. They assessed three therapeutic case studies (eg Zolgensma, Yescarta and Rybrevant) and identified the main challenges during their assessment. The report is significant in that it set out a summary of conclusions and key considerations that provide an important framework for future HTAb and regulatory collaboration on both improved evidence generation strategies as well as solutions for mitigating the identified uncertainties.

The European Medicines Agency (EMA) has released guidance on the anonymisation of personal data and assessment of commercially confidential information during the preparation and redaction of risk management plans (RMPs) (body and Annexes 4 and 6) for applicants or marketing authorisation holders during the scientific review of a medicinal product. The guidance is to be used for the retention or removal of personal data and identification of commercial confidential information when drafting of RPMs during the pre-approval process and for the redaction of the RMPs for publication post-approval.

The European Medicines Agency (EMA) has published an interim report covering its pilot programme for Expert Panel advice to manufacturers of high-risk medical devices, which ran from February 2023 to December 2024. The report analyses 51 applications received across three submission phases, with 20 finalised advice procedures completed. Following the pilot's success, EMA fully implemented the regular advice procedure in February 2025, establishing the first EU-wide regulatory pathway for manufacturers to receive expert guidance on clinical development strategies and investigation proposals for high-risk devices.

The European Medicines Agency (EMA) has released an updated Q&A guidance document for applicants, marketing authorisation holders and notified bodies of medical devices regarding the implementation of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)). The document provides regulatory and procedural guidance for integral drug-device combined products such as pre-filled syringes and lifecycle management, co-packaged devices with medicinal products, the consultation procedure for medical devices with an ancillary medicinal substance and the consultation procedure for companion diagnostics (ie diagnostic tests that are essential for the correct use of a specific medicine).