The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published guiding principles for using large language models (LLMs) across the European medicines regulatory network (EMRN). These guidelines, which form part of the AI workplan to 2028, aim to help staff at regulatory agencies effectively harness the potential of LLMs while addressing challenges like variability, data security risks, and result accuracy. The guiding principles also highlight the importance of protecting personal data while using LLMs at the user and organisational level, and emphasise the need for critical thinking and training. The guiding principles also include general ethical considerations for using LLMs including human dignity, autonomy, rule of law, accountability, security, safety etc, which draw from several sources. A webinar, to be held on 13 September 2024, will introduce these guidelines to the EMRN.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a horizon scanning report analysing current developments and emerging trends in the field of radiopharmaceuticals, alongside associated regulatory challenges. The report provides recommendations to help the European Medicines Regulatory Network reduce regulatory bottlenecks, support developers and facilitate the delivery of innovative medicines to patients. It identifies several key challenges, including compartmentalisation between EU pharmaceutical and radiation protection legislation, limited access to approved radiopharmaceuticals, radionuclide supply shortages and insufficient expertise and multidisciplinary collaboration. The report sets out recommendations across four key areas: (1) updates to the regulatory framework; (2) stakeholder engagement and knowledge exchange; (3) development of additional knowledge and technical expertise and (4) strengthening manufacturing and supply chains.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published their draft joint EU network strategy to 2028 (EMANS 2028) for consultation. EMANS 2028 is a review and update of the original five-year 2021–2025 strategy (EMANS 2025). This update is necessary due to environmental changes, technological advances like AI, and ongoing reforms to the EU's pharmaceutical legislative framework. The strategy aims to enhance medicine accessibility, foster the adoption of new technologies, accelerate innovation, reduce shortages, and establish a sustainable regulatory network prepared for future challenges. EMANS 2028 will be finalised between December 2024 and March 2025, followed by sign-offs from the EMA and HMA, with the final publication expected in early Q2 of 2025. Interested stakeholders may provide their input until 30 November 2024.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint workplan titled ‘Data and AI in medicines regulation to 2028’ outlining their strategy for optimising the use of data and artificial intelligence (AI) in medicines regulation through to 2028. The workplan details how the European medicines regulatory network will manage, analyse, and share regulatory and health data and provides a framework for addressing new EU legislative initiatives, including the European Health Data Space, Interoperable Europe Act, and EU AI Act. It also aims to streamline the discovery, access, and use of the network’s data assets by cataloguing and enhancing data quality, focusing on real-world data, adverse drug reaction data, and medicinal product master data. In addition, the workplan will advance the implementation of the Product Management Service (PMS), which serves as the network’s source of product master data for all EU medicinal products. Key initiatives also include supporting EMA’s scientific committees and the pharmaceutical industry in evaluating AI throughout the medicines lifecycle and developing guidance on the use of AI in clinical development and pharmacovigilance, among other areas. The Network Data Steering Group will oversee the implementation of the workplan.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued recommendations to strengthen Europe's production capacity for radiopharmaceuticals, which use radioactive isotopes for diagnosing or treating conditions like cancer. Due to increasing demand and limited manufacturing capacity, Europe faces occasional shortages and are vulnerable to supply chain disruptions.

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have issued a joint warning. There has been a significant rise in the sale of illegal medicines across the EU, particularly unauthorised products falsely marketed as GLP-1 receptor agonists like semaglutide and liraglutide, intended for weight loss and diabetes. These medicines are often sold through fraudulent websites and social media, posing serious health risks due to poor quality, incorrect ingredients or harmful substances. Patients using these products face dangers such as treatment failure, severe side effects and harmful drug interactions.

The European Medicines Agency (EMA) and International Council for Harmonisation (ICH) have published two new Step 2b guidelines in April 2025. The ICH M15 guideline, published on 16 April, establishes a harmonised framework for evaluating model-informed drug development evidence, while the ICH Q1 guideline on stability testing of drug substances and products was released on 11 April. Both guidelines aim to standardise pharmaceutical development processes across jurisdictions. The M15 guideline follows a consultation period that concluded on 28 February 2025, while the Q1 guideline has now entered its public consultation phase.

The European Medicines Agency (EMA) has announced that the World Health Organization (WHO) has designated the European Medicines Regulatory Network (EMRN) as a WHO Listed Authority. This means that the EMRN, which is made up of European Commission, EMA and the 30 national authorities of the European Economic Area Member States, are recognised as meeting international regulatory standards, guidelines and practices. Broadening focus to the EMRN and the United States Food and Drug Administration (FDA) as WHO Listed Authorities (WLA) Framework. The European pharma industry has responded with a statement that it views these additions to the WLA Framework as 'another crucial step in enhancing international cooperation to promote access and supply of safe, effective and quality medical products' through the sharing of work products and relying on decisions of globally trusted agencies

The European Medicines Agency (EMA) has issued guidance for marketing authorisation holders regarding the submission of variations for 2024. The Agency recommends that type IA and type IAIN variations be submitted no later than 30 November 2024 to ensure acknowledgement of validity within the 30-day timeframe stipulated by Commission Regulation (EC) No 1234/2008, before the EMA's closure from 20 December 2024 to 5 January 2025. Similarly, type IB variations or groupings of type IBs and type IAs should be submitted by the same date to commence procedures in 2024. Submissions received after 1 December 2024 may not be processed until January 2025. The EMA has provided guidance documents and contact information for procedural, regulatory, and fee-related queries to assist marketing authorisation holders in preparing their submissions.

The European Medicines Agency (EMA) has published its 2024 annual report, outlining its evaluation and monitoring activities for human medicines across the EU. Executive Director Emer Cooke confirmed that EMA recommended 114 medicines for authorisation in 2024—the highest number in 15 years—with 46 containing new active substances and 16 intended to treat rare diseases. Notable approvals included treatments for early Alzheimer’s disease, haemophilia B, ALS, and the first adult Chikungunya vaccine. Cancer remained the leading therapeutic area, with 28 recommendations, including biosimilars addressing various oncological and immunological conditions.

The European Medicines Agency (EMA) has complied a list of procedures and templates to support the exchange of inspection-related information and enhance co-operation between Member States. The compilation includes procedures to support inspections of manufacturers and wholesale distributors and templates used by the good manufacturing practice (GMP) and good distribution practice (GDP) inspectorates. These materials aim to cover the national procedures which are part of the national inspectorates’ quality system. Materials include guides on quality systems framework for GMP inspectorates, conduct of inspections of pharmaceutical manufacturers and importers, GDP inspection procedure and a model for risk-based planning for inspections of pharmaceutical manufacturers.

The European Medicines Agency (EMA) has launched a public consultation on its draft reflection paper on the use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE). The reflection paper discusses the methodological aspects of NIS using RWD to generate RWE for regulatory purposes and makes a distinction between NIS having descriptive and causal objectives. The consultation will close on 31 August 2024.