The European Medicines Agency (EMA) issued a guideline for consultation that sets out the type of information required to develop, manufacture, and control new and existing synthetic oligonucleotide drugs 'which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) and Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017)'. The need to devise a guideline was proposed in 2022 further to increasing interest in and trials with these products. The draft guideline follows the US Food and Drug Administration’s publication earlier in 2024 of a finalised guidance on its expectations for clinical pharmacology studies for oligonucleotides. EMA states that manufacturers should adhere to the principles outlined in the International Council on Harmonisation’s (ICH) Q8 guideline on pharmaceutical development, the ICH Q9 guideline on quality risk management, and the ICH Q11 guideline on developing active drug substances. The guideline also includes information to support the generic development of these drugs. It makes clear that clinical data to support these applications will evolve. The deadline for submitting public comment is 31 January 2025.

The European Medicines Agency (EMA) has launched an EU survey ran by the joint HMA-EMA Network Data Steering Group (NDSG) to identify key research priorities for artificial intelligence (AI) in the development and evaluation of medicines. It aims to gather structured input from stakeholders including the European Medicines Regulatory Network (EMRN), industry, SMEs, patients, consumers, academics and healthcare professionals. Survey feedback will be used to define priority areas that can support safe and effective use of AI in medicine, with the findings to be shared with the broader research community to advance academic and multi-stakeholder research. The survey forms part of the NDSG’s 2025–2028 workplan to optimise data use and leverage AI for better decision-making in medicines regulation. The survey closes on 17 October 2024.

The European Medicines Agency (EMA) has developed the European Shortages Monitoring Platform (ESMP) in accordance with Regulation (EU) 2022/123 to systematically collect and analyse data regarding medicine supply, demand, and availability across the EU and EEA. The document, presented in the form of frequently asked questions, delineates the legal basis, definitions, and operational requirements concerning shortage reporting. Marketing authorisation holders (MAHs) are required to report all potential and actual shortages of centrally authorised products, with a defined transition period that commenced in November 2024 and became mandatory from 2 February 2025. The ESMP has been designed to function across three distinct phases—routine monitoring during normal circumstances, crisis management during public health emergencies or major events, and MSSG‐led preparedness reporting—ensuring that reporting protocols are adapted to the specific context of the shortage event. Furthermore, the platform is integrated with other EMA systems, such as IRIS, PMS, OMS, and RMS, to facilitate the pre-population of product information, data validation, and efficient reporting processes while upholding data confidentiality and accuracy. The comprehensive guidance provided in the document clearly outlines procedural obligations, reporting timelines, and data update requirements, thereby reinforcing the EMA’s commitment to safeguarding public health through robust, harmonised, and timely monitoring of medicine shortages.

The European Medicines Agency (EMA) has implemented a new clinical trial mapping tool within the Clinical Trials Information System (CTIS), marking a significant development in the accessibility of EU clinical trial data. The tool, launched as part of the Accelerating Clinical Trials in the European Union initiative's 2025-2026 workplan, enables healthcare professionals and patients to search for ongoing trials by location and medical condition, with functionality for lay language queries and spelling corrections. The system provides direct investigator contact information for trial enrolment enquiries and will initially operate in English, with additional EU language support planned. This development advances the transparency objectives of the Clinical Trials Regulation, whilst maintaining the existing framework where EU/EEA Member States retain authority over trial authorisation and oversight, with the European Commission maintaining regulatory supervision.

The European Medicines Agency (EMA) has launched a consultation on the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline M13B, which outlines recommendations for obtaining waivers of bioequivalence (BE) studies for additional strengths of a drug product in applications where in vivo BE has been established for at least one strength. The guideline applies during both the development and post-approval phases for orally administered immediate-release solid dosage forms, such as tablets, capsules, and granules/powders for oral suspension, that are designed to deliver drugs to the systemic circulation. This is the second in a series of ICH guidelines focusing on the scientific and technical aspects of demonstrating BE for additional strengths of a drug product. The consultation closes on 9 July 2025.

The European Medicines Agency (EMA) has launched a two-month public consultation on proposals to make Annex 15 qualification and validation guidelines mandatory for active substance manufacturers. Currently, these guidelines serve as optional supplementary guidance, but they would become compulsory in light of the lessons learned from the N-nitrosamine contamination in sartan medicines identified in 2018. Comments on the proposals are due by 9 April 2026, with the final publication anticipated by December 2026.

The European Medicines Agency (EMA) has released a draft reflection paper proposing to reduce clinical data requirements for biosimilar approvals. The paper suggests waiving comparative efficacy studies for biosimilars that demonstrate high similarity through analytical and in vitro testing. The consultation considers adjustments to pharmacokinetic study requirements and immunogenicity parameters. The proposals build on EMA's February 2024 concept paper and reflect increased confidence in analytical characterisation methods for establishing biosimilarity. The consultation will be open until 30 September 2025.

The European Medicines Agency's (EMA) GMP/GDP Inspectors Working Group has opened a public consultation on revising Part IV Guidelines on Good Manufacturing Practice for Advanced Therapy Medicinal Products. The revision will align with Annex 1 requirements, incorporate ICH quality management principles, and update legal references for human-origin materials. The draft guideline is expected in September 2026, with final adoption planned for March 2027. When implemented, it will replace the current Eudralex Volume 4: Part IV GMP specific to ATMP guidelines. The consultation runs from 8 May to 8 July 2025.

The European Medicines Agency (EMA) has published a draft reflection paper on non-human primates (NHPs) in safety testing of human medicinal products and opportunities for 3Rs (replacement, reduction and refinement) implementation. The paper outlines scientific and regulatory considerations for NHP use in non-clinical safety testing and highlights opportunities to apply the 3Rs principles within existing guidelines to limit NHP use to a last resort where scientifically justified. EMA has also launched a consultation on the reflection paper, which closes on 31 January 2026.

The European Medicines Agency (EMA) has announced the full operationalisation of the European Shortages Monitoring Platform (ESMP) as of 29 January 2025. This platform, a key component of EMA's extended mandate, will become mandatory for marketing authorisation holders and national competent authorities from 2 February 2025. The ESMP facilitates the reporting and monitoring of medicine shortages for both nationally and centrally authorised products during crises and preparedness actions. It introduces harmonised reporting standards to enhance data usability and expedite coordinated actions to prevent and mitigate shortages across the EU and european economic area. The platform also provides public access to information on individual medicine shortages through EMA's shortages catalogue, marking a significant advancement in the EU's approach to managing medicine availability.

The European Medicines Agency (EMA) has published an infosheet following its meeting on 11 November 2024, updating its Antimicrobial resistance (AMR) website. EMA has characterised AMR as a 'growing silent pandemic' that demands immediate and decisive action.

The European Medical Agency (EMA) is launching a new submission management system, IRIS, from 23 January 2024 and is decommissioning its previous management system (SIAMED). IRIS is set to become the communication portal between the EMA, EU Network and applicants, and will exclusively impact centrally authorised products (CAPs). For its initial rollout it will handle Variations and Art. 61(3) notifications under Directive 2001/83/EC, variations requiring assessment under Regulation 2019/6 and Marketing Authorisation transfer applications for certain types of human and veterinary medicinal products. In advance of its rollout this month, the EMA has issued Q&A guidance about the regulatory procedure for the product lifecycle management.