The European Medicines Agency (EMA) has published a draft reflection paper outlining proposals to utilise existing two-dimensional DataMatrix codes on medicine packaging to provide patients with access to electronic product information. The paper forms part of the European Medicines Regulatory Network's development of electronic product information for human medicines, aiming to integrate creation and updates into routine regulatory procedures. The approach would use existing falsified medicine requirement codes without requiring packaging changes. The consultation seeks feedback on this approach until 30 June 2025.

The European Medicines Agency (EMA) has opened a consultation on its draft revised policy regarding the handling of competing interests among scientific committee members and experts (Policy 0044). This revision follows recent Court of Justice rulings in Joined Cases C-6/21 and C-16/21 P and Case C-291/22 and aims to eliminate doubts regarding the objective impartiality of EMA’s assessments. While the EMA has always prohibited individuals currently employed by or holding financial interests in a pharmaceutical company from participating in its activities, the revisions increase and align restrictions across roles and groups for experts with current interests in a product, as well as those with past employment in a pharmaceutical company. Additionally, the revision strengthens handling of competing interests in the medical device industry, introduce new rules to address certain interests in research organisations, and further clarify the use of expert witnesses. Comments on the draft revised policy can be submitted until 10 November 2024.

The European Medicines Agency (EMA) has issued a draft qualification opinion on the use of virtual control groups (VCGs) in preclinical rat dose-range finding studies, which can reduce the overall number of animals used by replacing concurrent control groups with ‘virtual animals.’ The opinion confirms that evidence generated using this new approach methodology can be accepted as scientifically valid within a defined context of use, provided study outcomes and human safety are not compromised. The consultation closes on 12 May 2026.

The European Medicines Agency (EMA) has initiated the development of a new guideline on the assessment and reporting of mechanistic models used in model-informed drug development. These models, which integrate various biopharmaceutical and pharmacological processes, are increasingly utilised throughout drug research and development. The guideline aims to address the challenges regulators face in assessing and quantifying risks associated with decisions based on these complex models. It will cover models such as Physiologically Based Pharmacokinetic (PBPK), Physiologically Based Biopharmaceutics (PBBM), and Quantitative Systems Pharmacology (QSP). The EMA has opened a concept paper for public consultation until 31 May 2025, seeking input on key metrics, components, and acceptance criteria for the technical assessment of mechanistic models.

The EMA and the European Commission established the Combination Products Operational Group (COMBO) in October 2025 and launched it on 4 November 2024. The group aims to facilitate dialogue on regulatory challenges, foster alignment and coordination in the assessment of products at the intersection of pharmaceutical and medical device frameworks. COMBO brings together experts from competent authorities respectively for medicines and medical devices, as well as Notified Bodies. It will explore potential regulatory solutions for combination products and consultation procedures for certain devices with the aim to develop and update guidance. It is structured to focus on two streams: medical devices and diagnostic devices. It convenes its first meeting on 7 November 2025.

The European Medicines Agency (EMA) has established a regular procedure for manufacturers of certain high-risk medical devices to request scientific advice on their clinical development strategies. The agency now allows manufacturers of class III devices and class IIb active devices intended to administer or remove medicines to submit requests via a portal for consultation with medical device expert panels. This follows a successful pilot launched in February 2023. EMA has also initiated a separate pilot programme, running until the end of 2025, to support orphan medical devices, with new guidance on clinical evaluation of such devices published by the Medical Devices Coordination Group in June 2024.

The European Medicines Agency (EMA) has released two guidance documents regarding biological and chemical agents, highlighting medicines that can be used for treatment and prophylaxis in case of exposure to biological or chemical agents used as weapons of terrorism, crime, or warfare. The guidance documents provide information on decontamination, supportive treatment, and specific antidotes for various biological and chemical agents. They both also outline general decontamination principles and symptomatic treatment measures, highlight the EU marketing authorisation status of these medicinal products and provide information on their dosing, administration, and use in special populations like pregnancy and lactation.

The European Medicines Agency (EMA), in collaboration with the Heads of Medicines Agencies (HMA), has issued an addendum to its good pharmacovigilance practices (GVP) guidelines, specifically addressing the masking of personal data in individual case safety reports (ICSRs) submitted to EudraVigilance. This update follows an audit by the European Data Protection Supervisor, which highlighted the need for a unified masking policy across all entities reporting to EudraVigilance. The addendum outlines which data elements should be masked, left blank, or retained based on their relevance to pharmacovigilance processes such as signal management, duplicate detection and case processing.

The European Medicines Agency (EMA) has introduced the Scientific Advice for Clinical Trial Authorisation (SA-CTA) procedure to streamline and harmonise regulatory and ethical guidance for medicines developed in response to public health emergencies, including antimicrobial resistance. The framework, established under Regulation (EU) 2022/123, integrates expertise from the Clinical Trial Coordination Group , Member States, National Competent Authorities and the Public Health Emergency Ethics Advisory Group, created under the Accelerating Clinical Trials in the EU initiative. Developers applying for Emergency Task Force (ETF) advice through the EMA’s IRIS portal can obtain coordinated input on both clinical trial design and marketing authorisation requirements, ensuring early alignment between regulatory and ethical standards.

The European Medicines Agency (EMA) has advised marketing authorisation holders to submit type IA and type IAIN variations and super-groupings by 21 November 2025, and type IB variations by 30 November 2025, to ensure processing before the agency's closure from 23 December 2025 to 5 January 2026. The guidance follows the new Variations Regulation (Regulation (EC) No 1234/2008 as amended) that came into force in January 2025, with new Commission variation guidelines taking effect from 15 January 2026 to reflect the 2024 regulatory amendments. The 21 November 2025 deadline for type IA submissions is set to enable the EMA to acknowledge the validity of submissions within the required 30-day timeframe under Article 14 of Commission Regulation (EC) No 1234/2008. For type IB variations, submissions received on or after 1 December 2025 may not begin processing until January 2026.

The European Medicines Agency (EMA), through its Committee for Human Medicinal Products (CHMP) and Methodology Working Party (MWP), has published a final Reflection Paper (EMA/99865/2025) offering scientific guidance on the use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes. This follows a public consultation process conducted between May and August 2024, during which 39 stakeholders submitted 695 comments. The final version, adopted on 17 March 2025, incorporates feedback gathered during this consultation and from prior stakeholder workshops.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released comprehensive guidelines to assist pharmaceutical companies in implementing Shortage Mitigation Plans (SMPs) and Shortage Prevention Plans (SPPs). These measures aim to address the escalating issue of medicine shortages across Europe, exacerbated by the COVID-19 pandemic, which has significantly impacted patient care and treatment availability.