The European Medicines Agency (EMA) has launched an 18-month voluntary pilot of a revised pre-submission interactions (PSI) model for initial marketing authorisation applicants. The pilot introduces earlier, structured engagement between applicants, rapporteurs and the EMA to improve submission readiness, identify potential assessment issues before formal submission and support more predictable assessment timelines. It is intended to address applications submitted before the supporting data package is sufficiently mature, as these may result in delays, clock-stop extensions or the need to submit substantial additional data during assessment. The pilot is open to applicants planning to submit an initial marketing authorisation application between February 2027 and September 2028. It introduces written PSI with the EMA at least five months before the intended submission date and a joint EU submission, timelines and review talk (EUSTART) meeting at least three months before submission to discuss dossier maturity and confirm whether the application is ready for submission

The European Medicines Agency (EMA) has launched a pilot programme to support development of and quicker access to breakthrough medical devices in the EU while maintaining thorough safety and performance standards. The three-phase pilot offers enhanced regulatory support and priority scientific advice for highly innovative devices addressing unmet medical needs. Phase one covers class III (high-risk) devices and class IIb active devices for medicine administration or removing medicines from the body. The pilot expands on the 'Guidance on Breakthrough Devices' (the Guidance) published by the European Commission's Medical Device Coordination Group in December 2025.

The European Medicines Agency (EMA) has launched a pilot programme for the development and assessment of orphan medical devices in the EU. The programme provides free advice from medical device expert panels to certain manufacturers and notified bodies on the status of the orphan medical device and data required for their clinical evaluation. The pilot programme is currently scheduled to run until the end of 2025.

The European Medicines Agency (EMA) has launched three new features under its priority medicines (PRIME) scheme, following a two-year pilot, to enhance support for medicines targeting unmet medical needs. The features—a regulatory roadmap and product development tracker, expedited scientific advice, and a submission readiness meeting—aim to streamline scientific dialogue, provide faster responses, and help developers prepare for marketing authorisation applications. The EMA has indicated that these tools will become permanent PRIME features as it prepares for the revised EU pharmaceutical legislation.

The EMA has published a draft guideline, ICH E21, to promote the inclusion and retention of pregnant and breastfeeding individuals in clinical trials. Developed with global regulators through ICH, the guidance aims to address the lack of safety and efficacy data for this population, who are often excluded from trials despite frequent medicine use. Public consultation runs until 15 September 2025.

The European Medicines Agency (EMA) has opened a consultation on a concept paper proposing a reflection paper on proof-of-concept data supporting the development of anti-cancer medicinal products in paediatric patients. The paper identifies high-level recommendations for generating and assessing proof-of-concept data using a weight of evidence approach, considering factors such as mechanism of action, biology of paediatric malignancies, non-clinical disease models, pharmacokinetics and safety considerations. It also highlights challenges in paediatric oncology drug development, including biological differences between adult and paediatric cancers and limited clinical trial populations, and proposes stakeholder input, including academic experts, to inform the assessment of Paediatric Investigation Plans (PIPs). The consultation closes on 30 June 2026.

The European Medicines Agency (EMA) has published a draft revised guideline on quality requirements for radiopharmaceuticals, opening public consultation. The guidance replaces the 2007 radiopharmaceuticals guideline and provides comprehensive requirements for Module 3 quality documentation in marketing authorisation applications. It covers four product types: ready-for-use radiopharmaceuticals, kits for radiopharmaceutical preparation, radionuclide generators and radionuclide precursors. The consultation ends on 30 April 2026.

The European Medicines Agency (EMA) has released a concept paper calling for updates to the guidelines in data and labelling of medicines for their risk profile regarding fertility, pregnancy and breastfeeding. It is usually only non-clinical data that is available to provide safety information in the summary of product characteristics and the package leaflet after marketing authorisation (MA). Most data on human pregnancy exposures are collected following MA by spontaneously reported post-authorisation data, in patient/pregnancy registries, and through epidemiological studies undertaken in such data sources. After the adoption of the guideline in 2008, multiple developments in the non-clinical field of reproductive toxicology have taken place which have an effect on the interpretation of non-clinical data on the use of medicines during pregnancy and breastfeeding. The concept paper also proposes several ways the guidelines should be updated and its effect on labelling. The consultation will close on 31 August 2024.

The European Medicines Agency (EMA) has announced its readiness to support the implementation of Regulation (EU) 2021/2282 EU (the new regulation on health technology assessment (HTAR)) when it becomes effective on 12 January 2025. EMA will assist in joint clinical assessments, participate in joint scientific consultations, and facilitate information exchange. The regulation initially covers new cancer treatments and advanced therapy medicinal products, with plans to expand its scope in subsequent years. EMA has begun identifying relevant marketing authorisation applications and will collaborate closely with the HTA Coordination Group to ensure smooth implementation of the new framework.

The European Medicines Agency (EMA) has launched a consultation on reducing clinical data requirements for biosimilar approvals. The draft reflection paper proposes waiving comparative efficacy studies for biosimilars that demonstrate high similarity through analytical and in vitro testing. While pharmacokinetic studies remain mandatory, the agency is considering adjustments to study design requirements. The consultation aims to streamline the biosimilar approval process while maintaining safety standards. The paper also outlines quality assessment criteria and batch-to-batch variability requirements. The consultation will be running until the 30 September 2025.

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their joint EU medicines agencies' network strategy to 2028 on 18 March 2025. The strategy outlines six focus areas including AI implementation, regulatory science and antimicrobial resistance. During consultation, concerns were raised about the regulatory network's capacity to implement the strategy, though 19 out of 24 responses were positive, with two trade groups expressing neutral views. The strategy aims to address post-pandemic challenges and prepare for upcoming pharmaceutical legislation reforms, with emphasis on EU competitiveness in medicines development and manufacture.

The European Medicines Agency (EMA) has published draft guidance from the Accelerating Clinical Trials in the EU (ACT EU) initiative on the conduct of clinical trials during public health emergencies (PHEs). The guidance, which is now open for stakeholder consultation, recommends a harmonised approach to ensure trials can be initiated, adapted and continued efficiently and safely when emergencies arise. It outlines regulatory mechanisms to accelerate authorisation of new clinical trials and approve modifications to ongoing trials during a PHE and encourages sponsors to seek scientific advice from EMA’s Emergency Task Force (ETF) to support well‑designed trials capable of generating meaningful clinical evidence. It also addresses circumstances in which trial participants may need to be transferred across investigational sites, noting that adapted procedures may be required due to PHE‑related challenges, while emphasising that the rights, safety and well‑being of trial participants and the production of scientifically robust evidence remain central to regulatory decisions. The consultation closes on 30 April 2026.