New EU rules for health technology assessments become effective

EMA confirms its readiness to support the implementation of the new Health Technology Assessment Regulation, applicable as of January 2025. The regulation is an important step forward in accelerating and widening access to new medicines.

Read about the new EU health technology assessment rules 

Handling of competing interests: revised rules published

EMA publishes the revised version of its policies on the handling of competing interests of scientific committee members and experts and Management Board members.

Read about the revised competing interests rules 

EMA celebrates 30 years

EMA marks 30 years of operation, celebrating its evolving role at the centre of the EU, assessing and authorising safe, high-quality medicines for 450 million people and countless animals in Europe.

Read about EMA’s 30th anniversary 

European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU

The ESMP is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and NCAs to directly report information on supply, demand, and availability of nationally and centrally authorised medicines during crises and preparedness actions led by EMA’s MSSG.

Read about the European Shortages Monitoring Platform 

One Health: EU agencies united to tackle azole fungicide resistance in Aspergillus fungi

For the first time, the five EU health and environment agencies – EFSA (European Food Safety Authority), ECDC (European Centre for Disease Prevention and Control), ECHA (European Chemicals Agency), EEA (European Environment Agency) and EMA (European Medicines Agency) – supported by the JRC (Joint Research Centre), review how the use of azole substances outside human medicine affects public health.

Read about One Health action on azole fungicide resistance 

Clinical Trials Regulation becomes fully applicable

From 31 January 2025, all clinical trials in the EU, including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation.

Read about the new EU Clinical Trials Regulation 

Visit of Commissioner for Health and Animal Welfare, Olivér Várhelyi

The Commissioner for Health and Animal Welfare, Olivér Várhelyi, visits EMA and emphasises the importance of close cooperation with EMA to support his goals in the area of medicines availability, boosting innovation and reducing complexities in the EU regulatory system, for the benefit of public and animal health.

Read about the Commissioner’s visit to EMA 

EMA earns certification for its environmental efforts

EMA’s environmental management system has been certified with the Eco-Management and Audit Scheme (EMAS), recognising the Agency’s commitment to environmental sustainability.

Read about EMA’s environmental certification 

New clinical trial map launched in the EU

EMA launches an interactive map on the CTIS public website, enabling patients and healthcare professionals to easily access comprehensive, real-time information about clinical trials conducted in their area, increasing access to clinical research in the EU.

Read about the new EU clinical trial map 

New Management Board chair elected

EMA’s Management Board elects Rui Santos Ivo as chair of the Board for a three-year period.

Read about the new Management Board chair 

Joint strategy sets direction of EMA and EU regulatory agencies to 2028

EMA and HMA publish their joint EU medicines agencies’ network strategy to 2028 (EMANS), which will guide the European medicines regulatory network over the next few years to meet the challenges ahead, including preparing for, and responding to, public health emergencies and threats such as antimicrobial resistance.

Read about the EMA and EU medicines strategy to 2028 

EMA establishes regular procedure for scientific advice on certain high-risk medical devices

EMA, in close collaboration with the European Commission, establishes a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their intended clinical development strategy and proposals for clinical investigation.

Read about scientific advice for high-risk medical devices 

Visit of the European Parliament Public Health (SANT) Committee

A delegation of the European Parliament Public Health (SANT) Committee visits EMA in Amsterdam to discuss EMA's activities related to antimicrobial resistance.

Read about the SANT Committee visit to EMA 

First report on EU-wide sales and use of antimicrobials in animals

For the first time, all the 27 countries of the EU, together with Iceland and Norway, have collected and reported data on both sales and use of antimicrobials in animals in their countries. The findings are presented in the first European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance report.

Read about the report on EU-wide sales and antimicrobial use in animals 

Streamlining development and assessment of biosimilar medicines

EMA opens a public consultation on a reflection paper outlining a new approach that would potentially reduce the amount of clinical data required for the development and approval of biosimilar medicines.

Read about the reflection paper on streamlined biosimilar development 

Clinical Trials Information System designated as WHO primary registry

CTIS is designated as a primary registry by the World Health Organization within the ICTRP, formally recognising that it adheres to specific criteria for content, data quality and validity, accessibility, unique identification, technical capacity, and administration.

Read about the CTIS WHO registry status 

Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

EMA and HMA, through the MSSG, issue recommendations to address supply chain vulnerabilities for radiopharmaceuticals.

Read about radiopharmaceutical supply chain recommendations 

Leveraging the power of data for public and animal health

EMA and HMA publish a joint workplan "Data and AI in medicines regulation to 2028" outlining how the EMRN plans to leverage large volumes of regulatory and health data as well as new tools to encourage research, innovation, and to support regulatory decision making for better medicines that reach patients faster.

Read about data and AI in medicines regulation 

New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

EMA releases a new draft ICH guideline on how to include and/or retain pregnant and breastfeeding people in clinical trials for public consultation.

Read about the clinical trials guideline for pregnant and breastfeeding individuals 

Workshop on the use of Bayesian statistics in clinical development

EMA organises a workshop to explore the benefits and challenges of using Bayesian statistics in clinical development, gain insights into what should be included in upcoming guidance documents, and better understand current and emerging trial designs to ensure that future guidance is fit for purpose.

Read about Bayesian statistics in clinical development 

Strengthening supply chain of anti-D immunoglobulins

EMA and HMA, through the MSSG, issue recommendations to address supply chain vulnerabilities for anti-D immunoglobulins.

Read about anti-D immunoglobulin supply recommendations 

No activities and events this month

EMA and WHO mark ten years of collaboration to advance global access to medicines

EMA and WHO celebrate a decade of formal collaboration and shared commitment to address global health challenges.

Read about 10 years of EMA and WHO collaboration 

Warning about sharp rise in illegal medicines sold in the EU

EMA and HMA warn the public about the growing threat of illegal medicines being advertised and sold online across the EU.

Read the warning about illegal medicines online 

New variations guidelines to streamline lifecycle management of medicines

EMA welcomes the publication of the European Commission's new Variations Guidelines, which streamline the lifecycle management of medicines. They were developed with support from EMA and the EMRN.

Read about the new medicines variations guidelines 

New targets for clinical trials in Europe

The European Commission, HMA and EMA have jointly developed two new targets for clinical trials to monitor progress against the ambition to make the EU a more attractive destination for clinical research and improve timely access to innovative medicines for patients.

Read about new EU clinical trial targets 

A path to better include patients’ perspectives in the regulation of medicines

EMA releases a draft reflection paper on patient experience data for public consultation. These are data directly reflecting patients’ experience or preferences on treatments or outcomes, without any interpretation by a clinician or anyone else.

Read about the patient consultation reflection paper 

EMA partners with content creators to promote safe and responsible use of GLP-1 medicines

EMA launches its first social media campaign, #HealthNotHype, working with content creators across seven EU countries to raise awareness about the safe and responsible use of GLP-1 RAs.

Read about the GLP-1 medicines campaign 

ICMRA Summit 2025: EMA concludes its two mandates as chair

EMA's Executive Director Emer Cooke hands over her role of chair of ICMRA to Anthony Lawler from the Australian Therapeutic Goods Administration (TGA).

Read about EMA’s leadership transition at the ICMRA Summit 

Workshop on the use of external controls for evidence generation in regulatory decision-making

EMA organises a workshop to engage with external stakeholders to explore the opportunities and the potential use of external controls in the regulatory setting and to discuss related methodological challenges to draw causal conclusions.

Read about the workshop on external controls in evidence generation 

EMA launches #ItTakesATeam medicine shortages campaign

EMA launches the #ItTakesATeam awareness campaign, co-created with EU healthcare professional and consumer organisations, to highlight shared efforts to prevent and manage medicine shortages across the EU, and the role of each actor in supporting patients faced with these shortages.

Read about the medicines shortages campaign 

First EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection

EMA and HMA host the first EMA/HMA multi-stakeholder forum on EudraVigilance and signal detection to discuss the latest developments in adverse drug reaction case processing, signal management, and international guidance.

Read about the forum on EudraVigilance and signal detection 

Improved scientific advice for medicines for public health threats including antimicrobial resistance

EMA's Emergency Task Force improves its approach to scientific advice for the most promising medicines and vaccines under development for public health threats.

Read about improved scientific advice for public health threats 

New podcast series: Episode 1 explores the fight against antimicrobial resistance

EMA launches Inside EMA, a new podcast series about the science and the people behind medicines regulation in the EU.

Listen to the Inside EMA podcast series 

HMA/EMA multi-stakeholder workshop on AI

EMA and HMA host a workshop on AI to provide keynotes on AI state-of-the-art, to update stakeholders on the evolving regulatory environment and HMA/EMA activities on AI, and to discuss progress on the Data and AI workplan as well as AI use cases across the medicines lifecycle.

Read about the EMA/HMA AI workshop 

New data on antimicrobials sales and use in animals in the EU

The second ESUAvet annual surveillance report is published, consolidating data from the EU including Iceland and Norway in 2024. Together with the report, a new dashboard is launched allowing public access to data on the sales of antimicrobial veterinary medicinal products across the EU.

Read about the second ESUAvet annual surveillance report 

EMA welcomes political agreement on new EU pharmaceutical legislation

EMA welcomes the landmark political agreement reached by the European Commission, the European Parliament, and the Council of the European Union on the comprehensive reform of the EU pharmaceutical legislation.

Read about the new EU pharmaceutical legislation agreement 

Technology Capability Investment Plan published

EMA publishes a Technology Capability Investment Plan that guides the technology choices that drive EMA’s and the Network’s digital transformation.

Read the Technology Capability Investment Plan