Day

April 3, 2025

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For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

EMA communications and newsletters

In 2024, we revamped the format of the monthly Human Medicines Highlights Newsletter for patients and healthcare professionals. It is a key tool to receive the latest news about medicines in the EU (subscribe). EMA also publishes other newsletters providing updates on various topics. An overview of all newsletters available for subscription can be found here: Newsletters | European Medicines Agency (EMA).

We encourage you to consider subscribing to the newsletters relevant to your areas of interest.

In parallel, as the number of EMA communications by email continues to increase, we would like to strike the right balance between the need to inform our stakeholders and minimise information overload. We will therefore keep targeted communications to stakeholders only for information requiring an action from our stakeholders (e.g. invitation to events, public consultations) or communications that may be more time-sensitive (e.g. urgent communications related to the safety of a medicine or other news of high public interest).

We hope that you find this information useful and remain open to receive any feedback to improve our communication and engagement efforts.

EMA communication: Human Medicines Highlights Newsletters

The Human Medicines Highlights has been revamped! Our monthly newsletter is now using a new tool, Newsroom, used for all European Commission newsletters.

It is important to subscribe as your current subscription will not be automatically transferred, all you need to do is click here and enter your email address to automatically subscribe to it.

Alternatively <<< CLICK HERE >>> to access the March 2025 issue

If you have any questions about the Human Medicines Highlights newsletter, or any comments or feedback, please send us an email at public-engagement@ema.europa.eu We would appreciate your feedback!

EMA communication: Veterinary Medicines Highlights

Quarterly news, activities and interviews from EMA Veterinary Medicines Division" Newsletter - March 2025

Welcome to the 20th edition of the Veterinary Medicines newsletter. 2025 is the year when the new process for signal management is being fully embedded, following a pilot phase of testing and some experimentation which started with Regulation (EU) No. 2019/6 that became applicable in 2022. The final process is centered around work sharing between EU Member States for the assessment of signals and annual statements submitted by marketing authorisation holders. Following this model, all EU Member States contribute to pharmacovigilance activities for the medicinal products under their responsibility, based on the type of authorisation.

We have some additional focus areas, such as finalising the EudraVigilance Veterinary (EVVet) best practice guide for industry, which will offer support supplementing the existing VGVP modules, to facilitate high quality submissions of adverse events and signals.

We look forward to launching a Veterinary Medicines Safety Day in April, targeting all stakeholders involved in pharmacovigilance activities and putting under the spotlight the importance of reporting adverse events. Finally, we also aim to update two key VGVP modules: on signal management and on communication.

We are looking forward to continued collaboration with the network and our stakeholders in 2025!

You can access the Newsletter by clicking here.

European Commission call for evidence: Have your say on the new Strategy for European Life Sciences - Deadline: 17 April 2025

We would like to share with you a call for evidence launched by the European Commission to gather input for the upcoming Strategy for European Life Sciences.

The strategy, announced will identify key challenges and opportunities to speed up the safe development, deployment and uptake of innovations based on life sciences.

Life sciences encompass the study of living systems, ranging from cells and microorganisms to plants, animals, humans and entire ecosystems. They play a pivotal role in many sectors, including human and animal health as well as food and agriculture. This is why they are key to supporting Europe’s green and digital transitions and to developing high-value technologies, which help tackle the most pressing challenges and enhance the health and well-being of citizens and of the planet.

The upcoming strategy will set out how to advance life sciences-based innovation across Europe by tackling key barriers and unlocking new opportunities for growth and impact. Moreover, the strategy will aim to strengthen the generation of European knowledge in life sciences, which is essential for breakthroughs to emerge.

Overall, the strategy aims to help increase the EU’s prosperity, improve its preparedness, security and strategic autonomy, accelerate and enable the digital and green transitions, and sustain the quality of life and well-being of Europeans.

The call for evidence gathers the views of stakeholders including experts and of the general public, and provides them with an opportunity to help design the Strategy for European Life Sciences in a collaborative, transparent and inclusive way.

The call for evidence is available in all official EU languages and will close on 17 April 2025.

For more details, please click here.

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

We are pleased to share with you the first report on EU-wide sales and use of antimicrobials in animals.

For the first time, all the 27 countries of the European Union (EU27) 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. The data cover the year 2023, marking the beginning of a regular exercise that will result in yearly reports.

For more information, please click here.

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

EMA and the Heads of Medicines Agencies (HMA) have published their joint EU medicines agencies’ network strategy to 2028 (EMANS), following its recent adoption by the HMA and the EMA Management Board.

The strategy, titled ‘Seizing opportunities in a changing medicines landscape’, is a comprehensive update of the five-year strategy which was developed to cover the period 2021 to 2025 (EMANS 2025). The updated document 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.

The six focus areas of the strategy to 2028 build upon those in the EMANS to 2025 with the updated strategy placing more emphasis on the competitiveness of the EU in the development and manufacture of medicines, as well as the use of artificial intelligence throughout the medicines’ lifecycle. The ‘One Health Approach’ is introduced as a key aspect of the strategy, recognising that the health of humans, animals and the wider environment are closely intertwined.

Prepared in a post-pandemic setting, the strategy draws on the extensive experience gained from tackling COVID-19. It also takes into account the ongoing revision of the EU's pharmaceutical legislation, laying the groundwork for its implementation.

Ultimately, this strategy will support the network’s core work of evaluating and promoting the development of safe and effective medicines and ensuring they reach those who need them.

This communication and related content are published here.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

EMA communication: Veterinary medicines in 2024

We are pleased to share the 2024 veterinary medicines booklet, which provides an overview of EMA key recommendations of 2024 regarding the authorisation and safety monitoring of veterinary medicines.

In 2024, EMA recommended 25 veterinary medicines for marketing authorisation, the highest ever number of recommendations in a year. Of these, two had a new active substance which had not previously been authorised in a veterinary medicine in the EU. 14 were vaccines, including seven that had been developed by means of a biotechnological process.

Among the medicines recommended for marketing authorisation in 2024, 13 were for food-producing animals, such as chickens, pigs and cattle, and 11 were for companion animals, such as dogs and cats.

We would also like to remind you, if you have not yet done so, to subscribe to the Veterinary Medicines Highlight Newsletter, which showcases the activities of the Veterinary Medicines Division, ranging from stakeholder events, regulatory news, and activities in the margins of the Veterinary Big Data strategy to notable CVMP outputs.

3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025 - 2027 work plan from 09:30 to 10:30 (CET)

We are pleased to inform you that the 3Rs Working Party (3RsWP) is holding a plenary meeting to showcase the Agency's commitment to ensuring the implementation of 3Rs principles in the development and evaluation of human and veterinary medicinal products. Participants will include industry and trade associations, animal welfare organisations, research consortia and EU agencies. The meeting is by invitation only.

As part of this plenary session, the 3RsWP is also hosting a virtual public session on 2 April 2025 from 09:30 to 10:30 (CET). The public session will be broadcast and is open to all stakeholders.

The aim of the public session is to present the 3RsWP workplan for 2025-2027 and priorities for 2025, and to give stakeholders an opportunity to comment and provide their views on the working party's activities. The 3RsWP will consider all comments provided in the elaboration of the 2026 work priorities. It will also publish a report to share the stakeholders' views.

REGISTRATION OPEN until 17 March: EMA 30th anniversary Open Door Day on 9 May 2025

As part of the celebrations of its 30^th anniversary, the European Medicines Agency (EMA) is delighted to announce that it is hosting its first Open Door Day on Europe Day, 9 May 2025 from 9:45 – 16:00 (CEST).

The event will feature guided tours of the EMA building in Amsterdam throughout the day, with each tour accommodating up to 20 participants. The tours, held in English, will last 60 minutes and are free of charge.

Participants will visit various parts of the EMA building and hear how EMA staff and experts from around Europe work together to ensure that medicines are safe and effective for public and animal health in the EU.

To express your interest in participating in the Open Door Day, please register by 17 March using the link below. For more details, please see the programme.

Register

For any questions, please contact us at EMAOpenDoor@ema.europa.eu.

EMA consultation: Reflection papers on the current regulatory testing requirements for human and veterinary medicinal products and opportunities for implementation of the 3Rs

EMA’s 3Rs Working Party are pleased to share the recent publication of the revised Reflection Papers on the Current regulatory testing requirements for human and veterinary medicinal products and opportunities for implementation of the 3Rs. In these reflection papers, existing opportunities in regulatory guidance are identified, highlighting the flexibility for 3Rs implementation already available in clinical (veterinary), non-clinical and quality regulatory testing requirements. Furthermore, the ‘newly identified opportunities’ describe promising opportunities for 3Rs implementation which are not yet incorporated in guidance; this aims to raise awareness and encourage further development in these areas.

The working party highly values the input of all its stakeholders and welcomes comments on the revised reflection papers through the public consultation (see forms linked in the PDFs), which is open until 30 June 2025.

EMA communication: Two new vaccines against bluetongue recommended for approval

EMA has recommended the approval of the vaccines Bluevac-3 and Syvazul BTV 3 to protect sheep against bluetongue disease. Bluevac-3 is also approved for use in cattle. The disease is caused by the bluetongue virus, of which different types exist. These vaccines are shown to protect against the newly emerged serotype-3 bluetongue virus (BTV3), responsible for recent outbreaks in Europe, and against which vaccines currently approved at EU wide-level show little protection. For this reason, the vaccines were recommended for approval under exceptional circumstances.

Bluetongue is an infectious disease that affects wild and domestic ruminants including sheep, goats and cattle. It is contracted through the bite of Culicoides flies that have fed on infected animals. In this way, it can spread through herds and across different species. The disease severity varies for different animals and is worst in sheep, for whom it can often be fatal.

There is no public health risk associated with bluetongue disease, as the virus is not transmitted to humans through contact with animals or wool, or through consumption of milk or meat. However, vaccination can control disease spread, reducing economic losses, protecting livestock trade and preventing animal suffering.

Both Bluevac-3 and Syvazul BTV 3 contain an inactivated form of BTV3. While the inactivated form cannot cause the disease, it can still elicit an immune response, protecting vaccinated animals against infection and reducing disease spread. Both are available as ready-to-use suspensions for injection and contain adjuvants to help stimulate the immune response.

The efficacy of Bluevac-3 was investigated in two studies comparing the protection against the disease in vaccinated and unvaccinated lambs and calves. In both species, after two doses of the vaccine given 21 days apart, the vaccinated animals showed a reduction in the amount of virus in the blood. Lambs also showed a decrease in the severity of symptoms and in mortality. The efficacy of Syvazul BTV 3 was assessed through two studies in vaccinated sheep exposed to the virus. These showed a reduction in the amount of virus in the blood, in disease symptoms and mortality.

Based on the risk assessment conducted as part of the evaluation of all veterinary products, the vaccines are not expected to pose a risk to human or animal health or the environment, if used according to the product information.

The respective Committee for Veterinary Medicinal Products (CVMP) opinions will now be sent to the European Commission for adoption of the decisions on EU-wide marketing authorisations of the two vaccines.

This communication and related content are published here.

EMA consultation: Concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use

The European Medicines Agency has published for public consultation a Concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use.

This concept paper addresses the need to establish a Guideline on the quality aspects of mRNA vaccines. In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. It is expected that such developments will be seen in the field of vaccines for veterinary use, too. The scope of the guideline will be limited to mRNA vaccines against infectious diseases (including self-amplifying mRNA).

Comments should be sent to vet-guidelines@ema.europa.eu by 8 April 2025 using this template .

EMA consultation: VICH GL8(R) Stability testing for medicated premixes

The European Medicines Agency has published for public consultation the VICH GL8(R) guideline on Stability testing for medicated premixes.

This document is an annex to the parent guideline (VICH GL3(R)) on Stability Testing of New Veterinary Drug Substances and Medicinal Products and addresses the recommendations for stability testing of new Medicated Premixes. The parent guideline provides a general indication of the information on product stability generated, but the annex for Medicated Premixes leaves sufficient flexibility to encompass a variety of different practical and scientific considerations that are specific to the characteristics of the veterinary medicinal products being evaluated. Specific requirements for other stability studies which are important to consider for medicated premixes, such as segregation and homogeneity studies and analytical method validation are (to be) covered in a separate guideline.

Comments should be sent to vet-guidelines@ema.europa.eu by 31 May 2025 using this template.

EMA communication: First certification of a veterinary vaccine platform technology master file

EMA's Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate for a vaccine platform technology master file (vPTMF) which will support and accelerate the development and authorisation of new veterinary vaccines in the EU.

Vaccine platform technologies play an important role in animal and public health preparedness and the ability to respond to emerging animal and public health threats. They have a set of core components common to all vaccines based on the same platform, and can be adapted rapidly for use against emerging diseases.

This communication and related content are published here.

EMA communication: Harnessing AI in medicines regulation: use of large language models (LLMs)

EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using large language models (LLMs) in their work.

LLMs are a category of generative AI, whose applications can significantly support medicine regulators in their tasks and processes. Whether they are used to query the extensive documentation regulators routinely receive, to automate knowledge/data mining processes, or as virtual AI assistants in everyday administrative tasks – LLMs have enormous transformative potential.

However, LLMs also present challenges, e.g. variability in results, returning of irrelevant or inaccurate responses (so-called hallucinations), and potential data security risks. The purpose of the guiding principles is to build understanding of the capabilities and limitations of these applications among staff at regulatory agencies across the EU so that they can harness the potential of LLMs effectively and avoid pitfalls and risks.

The guiding principles cover various aspects of using LLMs, from ensuring safe input of data, to applying critical thinking and cross-checking outputs, to knowing whom to consult when concerns arise. Responsible use of LLMs requires familiarity with the tools. The importance of continuous learning is emphasised to keep pace with the fast-changing field.

Additionally, the principles encourage regulatory agencies to make efforts to support their staff in using LLMs. This includes defining governance on the use of LLMs, specifying permitted use cases, providing training and monitoring risks.

This communication and related content are published on the following webpage:

Harnessing AI in medicines regulation: use of large language models (LLMs) | European Medicines Agency (EMA) (europa.eu)

EMA communication: Guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy

The Committee for Veterinary Medicinal Products (CVMP) adopted a guideline on quality, safety and efficacy of veterinary medicinal products specifically designed for phage therapy at its October 2023 meeting.

Phage therapy is a potential alternative to combat bacterial infections, or a complement to antibiotic therapy. Some studies show that phage-antibiotic synergies are characterised by a reduced emergence of antibiotic and/or phage resistance in bacteria.

Regulation (EU) 2019/6 states that veterinary medicinal products specifically designed for phage therapy are considered novel therapies and, as such, the Novel Therapies and Technologies Working Party (NTWP) developed a guideline to address the regulatory, technical and scientific requirements applicable to veterinary medicinal products specifically designed for phage therapy.

This pioneering document within the European regulatory framework aims primarily to facilitate and to guide the authorisation path of bacteriophage products. Additionally, by providing a well-defined regulatory pathway, this guideline seeks to encourage the development of these innovative therapies, offering the necessary support to pharmaceutical companies to successfully bring their phage therapy products to the European market.

The newly adopted guideline represents a fundamental step towards the promotion of animal and human health as envisaged by the One Health approach.

For more details on this topic, please click here.

EMA communication: 3Rs Working Party meeting report on use of animals in the regulatory testing of medicines

The EMA has a long-standing commitment towards the application of the principles of Replacement, Reduction and Refinement (3Rs) in regulatory testing of human and veterinary medicinal products (HMPs and VMPs). This commitment is driven by the requirements as per Directive 2010/63/EU, as well as by the crucial need for better tools to predict quality, safety and efficacy of new medicinal products.

The newly established 3Rs Working Party (3RsWP) is a joint working party of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Veterinary Medicinal Products (CVMP). It advises these committees on all matters concerning the use of animals in the regulatory testing of medicines, with particular focus on the application of the so-called 3Rs principles - replace, reduce and refine.

In February 2023, the 3RsWP held a two-day plenary meeting to showcase the Agency's commitment to ensuring the implementation of 3Rs principles in the development and evaluation of human and veterinary medicinal products.

The aim of the public session was to present the 3RsWP work plan and to give an opportunity to stakeholders to comment and provide their views on the working party's activities.

We are pleased to share with you the meeting report, which shows an overview of the input received from stakeholders during the meeting and the future activities of the Working Parties.

EMA communication: Progress with EU-US mutual recognition agreement for inspections for veterinary medicines

On 31 May 2023, the European Union and the United States have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products. The Food and Drug Administration (FDA) has recognised the capability of 16 EU Member States to carry out good manufacturing practice (GMP) inspections for certain veterinary products at a level equivalent to the US. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines.

This follows the extension of the scope of the mutual recognition agreement (MRA) between the EU and the US to veterinary products on 11 May 2023.

The Member States whose GMP inspections for veterinary medicines are recognised by the FDA are Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Greece, Hungary, Ireland, Luxembourg, Netherlands, Poland, Portugal, Slovenia and Spain.

Teams from the European Commission (EC), EU national competent authorities (NCAs), EMA and the FDA continue working closely to ensure the timely assessment of the remaining 11 competent authorities of Member States now that the difficulties brought about by the COVID-19 pandemic have been largely removed.

The MRA allows regulatory authorities in the EU and the US to rely on the results of inspections of manufacturing sites for veterinary products conducted in the respective territories of the parties. The aim is to strengthen reliance on the inspection expertise and resources between EU and US regulators. From now on, the FDA should rely on inspections conducted by these 16 Member States also for veterinary products and EU Member States and EMA will rely on inspections conducted by the FDA.

Benefits of the MRA for EU authorities and the FDA include:

the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured;
prioritising inspections of medicine manufacturing sites for higher-risk cases;
reassuring users that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured;
improving the regulators’ ability to identify and address potential problems at manufacturing sites before they become a public health risk;
reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.
reliance on inspections conducted by the MRA partner waives the need for inspections during assessment of a marketing authorisation application or variation and hence contributes to faster access to medicines.

For more details please click here.

We are pleased to inform you that the EMA has published its academia collaboration matrix action plan that sets out how the Agency intends to create closer ties with academics and researchers in the next two and a half years.

It lists actions in five areas identified in EMA's Regulatory Science Strategy to 2025:

Regulatory science and partnerships;
Innovation and support to academia;
Communication;
Events strategy;
Trainings.

Consult the action plan:

To learn more about how EMA interacts with academia, please click here.

The EMA is pleased to inform you about the decision to waive all fees for scientific advice for academic researchers developing orphan medicines, to further encourage the development of treatments for rare diseases.

The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with a potential to benefit patients with rare diseases.

Early interaction with EU regulators is important for academia to understand the regulatory requirements and allow the generation of robust evidence needed to establish the medicines’ benefits and risks. This helps them to navigate the regulatory process and ultimately to translate their discoveries into authorised, patient-focused medicines.

Eligible applicants will include public or private higher education establishments awarding academic degrees, public or private non-profit research organisations whose primary mission is to pursue research, and international European interest organisations. These entities should not be financed or managed by private for-profit organisations in the pharmaceutical sector or have concluded any agreement with pharmaceutical companies concerning their sponsorship or participation to a specific research project for which a fee exemption is sought.

Please check the news item on the EMA’s website, or view the dedicated posts on Twitter and LinkedIn for more information regarding the academic fee waiver.

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