EMA communications
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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 January 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 - December 2024
Welcome to the 19th edition of the Veterinary Medicines Highlights. As we leave 2024 behind and reflect on the achievements of the Veterinary Biologicals Service, it is clear that this has been a remarkable and busy year for biologicals and emerging therapies. Let me walk you through our key achievements.
You can access the Newsletter by clicking here.
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.
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 .
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.
EMA consultation: Concept paper for the revision of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)
The European Medicines Agency has published for public consultation a Concept paper for the revision of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs).
This concept paper addresses the need to revise the “Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)” (EMEA/CVMP/IWP/594618/2010), which is based on the requirements of Directive 2001/82/EC. The focus of the revision of the guideline is to reflect current knowledge and the experience gained from the assessment of association claims and to align with Regulation (EU) 2019/6.
Comments should be sent to vet-guidelines@ema.europa.eu by 13 March 2025 using this template.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.
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.
The EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public and targeted consultations.
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:
Annual Report 2023
It gives me great pleasure to present to you the European Medicines Agency’s annual report for 2023, which provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).
The redesigned report outlines the highlights in the evaluation and monitoring of human and veterinary medicines and key achievements in EMA’s three major strategic areas in 2023: cancer medicines, data-driven medicine regulation, and transparency and communication. It also contains a selection of key figures and interesting trends that illustrate the broader work of EMA and its impact. The digital version of the report allows users to filter and interact with the data. Its responsive design eases the navigation on all devices, including smartphones and tablets. The report, however, is also available in the traditional, print-ready version in PDF format.
In 2023, EMA recommended the authorisation of 77 medicines for human use, including 39 with a new active substance. Many of these treatments represented significant progress in their therapeutic areas. Two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV) received a positive opinion from EMA’s human medicines committee (CHMP) for approval in the EU. EMA also recommended for approval the first advanced therapy medicinal product using the ground-breaking gene-editing technology known as CRISPR/Cas9 to treat two rare blood disorders (beta thalassemia and severe sickle cell disease). In addition, the Agency adopted two positive opinions for medicines for use in countries outside the EU.
In the area of veterinary medicines, EMA recommended 14 medicines for marketing authorisation. Of these, nine had a new active substance – a threefold increase compared to 2022. Nine were vaccines, including six new biotechnological vaccines.
In 2023, the Agency launched a new initiative, called ‘Cancer Medicines Pathfinder’, to further support the development and approval of cancer medicines which could have a meaningful impact on patient care. This initiative explores how EMA can improve medicines evaluation overall, applying the learnings from the COVID-19 pandemic. The report outlines the progress with the Cancer Medicines Pathfinder and its three pillars: accelerating assessments of medicines, strengthening dialogue with stakeholders, and communicating benefits and risks.
Understanding how we can efficiently analyse and use data to inform medicines regulation was a key priority for the Agency and the European medicines regulatory network in 2023. It is important to ensure that the EU regulatory system can take advantage of the full potential of data. The report highlights EMA’s significant progress around the use of data to drive innovation and regulation of medicines.
Building trust in medicines regulation through transparency and communication is also an important priority for EMA. The report draws attention to the Agency’s strengthened efforts to provide European citizens with timely, accurate and comprehensive information on medicines via EMA’s corporate website, social media channels and traditional media. It also describes how EMA’s communications activities supported the focus areas outlined in the European medicines agencies network strategy to 2025 and the Regulatory Science Strategy to 2025.
The second chapter of the report is dedicated to core statistics and trends illustrating the Agency’s activities in the regulation of medicines. More detailed statistical information about EMA can be found in the Agency’s annual activity report.
I would like to take this opportunity to thank you and your staff for the contributions to EMA’s work. The success and achievements described in this report are only possible because of the strong network that binds all our agencies together in our joint mission to protect public and animal health in the EU.
I hope that you find the annual report informative and helpful. If you have any comments or suggestions on the report, especially on the digital version, please take this survey. Your responses are completely anonymous and will help us improve future editions of the report.
EMA communication: One Health: How EU agencies are tackling environmental and public health together
Today, the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA) published a joint framework for action to strengthen cooperation to support the implementation of the One Health agenda in the European Union (EU).
One Health recognises the complex interplay between human, animal and plant health, food safety, the climate crisis and environmental sustainability. Implementing this approach across different sectors will be key to making the EU and its Member States better equipped to prevent, predict, detect and respond to health threats. It will mitigate the impact and societal cost of such threats, or even prevent their emergence, while also helping to reduce human pressures on the environment and safeguarding key societal needs such as food security and access to clean air and water.
A cross-agency task force will work on implementing the joint framework for action over the next three years (2024-2026), focusing on five strategic objectives: strategic coordination, research coordination, capacity building, stakeholder engagement and joint inter-agency activities. This will ensure that the scientific advice provided by the agencies is increasingly integrated, that the evidence base for One Health is strengthened and that the agencies are able to contribute with a common voice to the One Health agenda in the EU.
In November 2023, the five EU agencies that provide scientific advice on the environment, public health and food safety topics issued a joint statement expressing their shared commitment to supporting the One Health agenda in Europe.
On the occasion of the launch of the joint framework for action, the Executive Directors of the five EU Agencies reinforced their commitment to the One Health approach in a joint video statement.
For more information on One Health, please click here.
EMA communication: Multi-agency report highlights importance of reducing antibiotic use
Countries that have decreased their consumption of antibiotics in both animals and humans have seen a reduction in antibiotic-resistant bacteria. This is according to the fourth joint report on the integrated analysis of the consumption of antimicrobial agents and occurrence of antimicrobial resistance (AMR) in bacteria from humans and food-producing animals (JIACRA IV), published by the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA), and the European Medicines Agency (EMA).
Taking a One Health approach, which recognises the connection between the health of people and animals, the report presents data primarily collected between 2019 and 2021 on antibiotic consumption and AMR in Europe.
Full details about the project and the 4th joint report are available here.
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.
EMA communication: Big data use for public health: publication of Big Data Steering Group workplan 2022 - 2025
The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its third workplan that sets key actions to be delivered between 2022–2025.
The new workplan will allow to further enhance the efficient integration of data analysis into the evaluation of medicinal products by regulators. Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes and facilitating earlier patient access to new treatments.
The former Big Data Task Force carried out a thorough assessment of the challenges and opportunities posed by big data in medicines regulation, which culminated in 2020 in the publication of priority recommendations for regulators on the best approaches to use and generate data. The joint HMA-EMA Big Data Workplan 2022–2025 follows the key recommendations and includes mainly activities related to medicines for human use. However, the scope of some activities covers veterinary aspects, and a separate section in the workplan is fully dedicated to veterinary medicines.
For more details on the workplan’s deliverables and timelines, 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:
- https://www.ema.europa.eu/en/academia
- https://www.ema.europa.eu/en/partners-networks/academia#framework-for-collaboration-section
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.