The European Medicines Agency has updated its guidance on submitting paediatric applications. Use of the IRIS platform is mandatory for all key procedures and new templates have been introduced. Their use is encouraged from 11 August 2025 and will become mandatory from 8 September 2025. These include revised forms for scientific documentation and key elements, as well as new templates for responses to the paediatric committee and applicant clarifications. Submissions must follow specified formats and deadlines. Full procedural advice and templates are available via the IRIS platform.

The European Medicines Agency (EMA) has updated its guidance on paediatric investigation plans (PIPs), with key revisions published on 28 November 2025 covering stepwise paediatric investigation plans (sPIPs). The updated guidance introduces partial development programmes for innovative children's medicines, conditional on developing full PIPs once sufficient evidence becomes available, and relies on predefined steps agreed with EMA's Paediatric Committee. Additional updates include new guidance on extrapolation use in PIP submissions published in March 2025, and revised procedures for PIP transfers between legal entities published in January 2025. The guidance also reflects changes under Regulation (EU) 2024/568 on fees payable to EMA, which repeals previous fee regulations while maintaining fee waivers for paediatric applications, though administrative charges may apply for application withdrawals after 24 hours or negative validations. The stepwise approach applies where there is lack of crucial information needed to decide on certain parts of the paediatric investigation plan, such as whether clinical studies for whole age groups are necessary.

The European Medicines Agency (EMA) has updated its frequently asked questions (FAQ) guidance document on parallel distribution. The updated version includes changes to several responses concerning parallel distribution procedures, such as: (1) steps to take when an organisation’s details change; (2) what happens if a Notice for Parallel Distribution (PD) cannot be issued; (3) the obligations of parallel distributors following the issuance of a PD notice; (4) the impact of the Protocol on Ireland/Northern Ireland; and (5) clarification on who receives PD notices. In addition to these updates, EMA has added a new FAQ on the requirements for QR codes on packaging material.

The European Medicines Agency (EMA) has published guidance following the adoption of Commission Implementing Regulation (EU) 2025/1466, which amends Regulation (EU) No 520/2012. This regulation formally ends the signal detection pilot in EudraVigilance by Marketing Authorisation Holders (MAHs), requiring all MAHs with authorised medicinal products in the European Economic Area (EEA), including Northern Ireland, to monitor EudraVigilance data as an additional source of safety information. The deletion of Article 21(2) removes the obligation to submit validated signals via a standalone form, placing full responsibility for signal management on MAHs in line with Good Pharmacovigilance Practices (GVP) Module IX.B. MAHs must now revise their internal procedures to reflect these changes, ensuring EudraVigilance data is integrated into routine signal monitoring and assessments, with frequency adapted to product-specific risks. These requirements take effect 20 days after the regulation’s publication, with further updates to GVP IX expected in the second quarter of 2026.

The European Medicines Agency (EMA) has updated its pre- and post-authorisation and procedural advice for users of the centralised procedure. The update clarifies that no variations applications are required for changes in physical importation sites. Therefore, new manufacturing sites for physical importation do not need to be registered in the dossier of the marketing authorisation for the medicinal product by the manufacturer(s) responsible for the physical importation of the finished product.

The European Medicines Agency (EMA) has published updated guidance documents implementing Regulation (EU) 2024/1701 on variations to marketing authorisations for human medicines, which became applicable on 1 January 2025. The updates cover pre and post-authorisation procedures, different variation types, and worksharing arrangements. Key changes include new procedures for Type IA variations, mandatory work-sharing requirements, and specific provisions for vaccine variations during public health emergencies. The European Commission is reviewing additional variations guidelines with updates expected later in 2025. Applications submitted before 1 January 2025 continue under previous rules until completion.

The European Medicines Agency (EMA) has created a website collating updated guidance regarding paediatric medicine applications and procedures. From 4 June 2024, researchers and sponsors of drugs in development that need to address paediatric studies must submit applications through the EMA's IRIS platform for certain procedures, which include—initial paediatric investigation plan (PIP), modification of an agreed PIP Product-specific waiver, compliance check, annual report on paediatric deferred measures, confirmation of applicability of a class waiver, or inclusion of an indication within a condition and discontinuation of paediatric development.

The European Medicines Agency (EMA) has welcomed the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), stating that it represents an important step towards strengthening the resilience, security and sustainability of the European Union’s (EU) supply of critical medicines. EMA noted that, in the context of increasing global disruptions and recent medicine shortages, the proposed Act marks a significant milestone in efforts to improve the availability, supply and production of critical medicines and to address vulnerabilities in pharmaceutical supply chains that may put patients’ lives at risk and place a burden on healthcare systems.

The European Medicines Agency (EMA), the European Commission, and the Heads of Medicines Agencies (HMA)—the joint bodies behind the Accelerating Clinical Trials in the EU (ACT EU) initiative—released a revised ACT EU workplan. Covering activities for 2026 and 2027, the workplan outlines the essential role of ACT EU’s regulatory partners in enhancing the EU clinical research landscape. It reflects feedback received from a multi-stakeholder platform advisory group.

The European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) and the European Commission are launching two advice pilots to improve the quality of applications for clinical trials as part of their Accelerating Clinical Trials (ACT EU) initiative. The first pilot provides developers of medical products advice by the Scientific Advice Working Party and the Clinical Trials Coordination Group on clinical trials. The second pilot provides technical and regulatory support on pre-submission topics to the applicant prior to its submission of the clinical trial application. The pilot covers advice on regulatory aspects of low interventional clinical trial status and submission of trials with decentralised elements or complex designs. Interested developers may apply to these pilots from 11 June 2024.

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