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.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
We are pleased to inform you that we are relaunching our corporate website on 5 December 2023.
We are introducing helpful features, such as an easier way to find information on medicines through a tailored medicine search.
Rest assured that all information related to EMA's evaluation, approval, safety and withdrawal of medicines, as well as medicine shortages and the activities of EMA's committees will still be available on our updated website.
Please read on for a summary of what’s staying the same and what’s changing on EMA’s corporate website.
What’s staying the same: First of all, you will still be able to find us at https://www.ema.europa.eu/en
Also, most pages, documents and visuals will work as before. If any links to current pages change, we will ensure that redirects are put in place to guide you towards the information you need.
What’s changing: EMA’s new website will have a fresh look and feel, will be more secure and simpler to navigate, and will help better meet your needs.
Improved medicines search and simplified navigation: For instance, we will introduce:
- a dedicated, simple medicines search - we are bringing back this landing page, in an improved version, to help meet the needs of patients, healthcare professionals and other people who want to find information on centrally authorised medicines quickly;
- simplified navigation - instead of the blue menu on the left of the screen, the new website will use 'breadcrumbs', i.e. links at the top of each page that show you where you are on the website and that allow you to go back to higher-level pages easily.
Key pages will have different URLs: The following pages of particular interest to you and other civil society representatives will have different URLs as of 5 December:
- summary of opinion pages for EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Veterinary Medicinal Products (CVMP)
- withdrawn applications for new medicines
In these cases, we will redirect the current URLs to the new website.
Outdated links will no longer work: Unfortunately, our relaunched corporate website will no longer support links that refer to the version of the website from before September 2018. This means you will not be able to access EMA links starting with ‘http:’ anymore.
But we’ve prepared guidance in case you need to update and replace any such links on your website -
Guidance_for_civil_society_representatives_on_EMAs_corporate_website_relaunch_2_November_2023.pdf (137.9 KiB, 26 hits)
Improvements in 2024 and beyond: Next year we plan to improve our website search, enhance the option to subscribe to EMA content and change the way we present information on medicine shortages, among others. On the latter, we aim to transfer related content from documents onto web pages.
We will keep you updated and will be glad to get your feedback as we roll out more new features in 2024 and beyond.
Find out more: If you want to learn more about our corporate website relaunch and ask us questions, don't miss our presentation to the EMA Patients’ and Consumers’ and Healthcare Professionals’ Working Parties on 15 November 2023.
Get in touch: For any questions you may have on our corporate website relaunch, please contact us at newwebsite@ema.europa.eu.
Thank you for your interest and support.
We are pleased to send you our latest edition of the monthly Newsletter which includes decisions by our Scientific Committees and updates on medicines safety. We hope that you will find this useful and welcome any feedback.
You can access the Newsletter by clicking here. Previous editions can also be found on this page.
Veterinary Medicines Highlights - Issue 14
https://ec.europa.eu/newsroom/ema/newsletter-archives/49064
EMA consultation on veterinary guidelines
The European Medicines Agency has published for public consultation the following two papers:
The guideline defines acceptable data requirements for the demonstration of quality of veterinary medicinal products other than biologicals classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.
This guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 January 2024.
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.
HMA/EMA Big Data Stakeholder Forum, being held on 4 December 2023 - Registration opens until 20 November
We are pleased to announce that the registration is now open for the fourth HMA/EMA Big Data Stakeholder Forum to be held on 4 December 2023.
The main objectives of the Forum are to:
- inspire with opportunities for the future thanks to keynotes speakers;
- discuss with stakeholders data-enabled opportunities to improve medicines development and the EU;
- inform and strengthen collaboration with stakeholders and partners on the delivery of the data activities included the Network Strategy to 2025 (fourth update of the HMA-EMA Big Data Steering Group workplan).
To register for online participation via Webex, please provide the names, contact email addresses and details of the organisation represented to EUBDStakeholderForum@ema.europa.eu.
To ensure a balanced stakeholder representation, we kindly ask you to nominate a maximum of 2 attendees from your organisation to participate.
Please note the meeting registration deadline is 20 November 2023.
A live broadcast will also be available to listen to the presentations and discussions, no registration is required for the broadcast option. A link to access the broadcast will be available via the event webpage.
Please follow the event page to find the latest Forum programme.
Should you have any questions about this event, please email: EUBDStakeholderForum@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 consultation: Veterinary concept paper and guidelines
The European Medicines Agency has published for public consultation the following veterinary concept paper and guidelines:
- The Guideline on user safety of topically administered veterinary medicinal products is planned to be revised in relation to the possible inclusion of reference to current EU-standards in the assessment of dermal absorption, i.e. ‘EFSA guidance on dermal absorption’ (EFSA Journal 2017; 15(6):4873) and to updated OECD ‘Guidance notes on dermal absorption’ No. 156. The revision could also include developments on the toxicological reference values, defaults and exposure calculations (e.g. absorption factors, appropriateness of the default values and of the wipe test) and risk mitigation measures:
- The importance of the availability of veterinary medicinal products is well recognised in the EU. Veterinary medicinal products legislation has been revised with the aim of reducing the administrative burden, enhancing the internal market and increasing the availability of veterinary medicinal products, while guaranteeing the highest level of public and animal health and environmental protection. This led to the introduction of specific provisions for limited markets in Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products repealing Directive 2001/82/EC (the Regulation). Article 4(29) of the Regulation provides a definition for limited market and Article 23 allows for the submission of a reduced package of safety and efficacy data when certain conditions are met:
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- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
Deadline: 31 January 2024 - Guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 8 2019/6
Deadline: 31 January 2024 - Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets
Deadline: 31 January 2024
- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6
Comments should be provided using this template and sent to Vet-guidelines@ema.europa.eu by the indicated deadlines.
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: Invitation to the 3rd Veterinary Big Data Stakeholder Forum on 23rd November 2023
The European Medicines Agency is pleased to announce its upcoming annual Veterinary Big Data Stakeholder Forum to be held on Thursday, 23rd November 2023, 13:00-16:30 CET.
The third edition of the event will offer an overview of the EU Veterinary Data Hub's activities and the Human Medicines Agency/EMA Veterinary Big Data work plan. It will also include a review of the identified use cases while gathering inputs and insights from experts. Additionally, the event will continue discussions on the upcoming challenges and future requirements of big data within the veterinary regulatory field.
The draft programme will be published in the upcoming weeks but interested parties can already register here to attend the event virtually.
To attend the event in person, please register your interest by email to vet-events@ema.europa.eu by 16th November.
EMA communication: EU Veterinary Big Data Workplan to 2025
We are pleased to announce the publication of the 4th Big Data Steering Group Workplan 2023-25 on the EMA website.
In line with the agreed Big Data Steering Group (BDSG) recommendations, the updated workplan continues to evolve to further enable the use of big data and establish their value to support the EU regulatory decision making process, to continue collaborative and harmonisation efforts at a global level and to engage with all stakeholders and partners.
The EU Veterinary Big Data Workplan to 2025 has been added, detailing the plans to increase the use of big data in the veterinary domain.
Please feel free to disseminate this email to anyone else who might be interested in this information.
EMA communication: A draft reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle
We are pleased to inform you that the EMA has published for public consultation a draft reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle to support the safe and effective development, use and regulation of human and veterinary medicines. This paper reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting.
EMA invites all interested partners and stakeholders to engage in a dialogue on AI in relation to medicines by providing their feedback using this EUSurvey form. The public consultation is open until 31 December 2023.
The reflection paper, co-developed by the Big Data Steering Group, the Committee for Medicinal Products for Human Use (and its Methodology Working Party) and the Committee for Veterinary Medicinal Products (CVMP) is part of the joint HMA-EMA Big Data Steering Group (BDSG) initiatives to develop the European Medicines Regulatory Network’s capability in data-driven regulation.
For more details, the news announcement and related content are available here.
In case of questions on the paper, please contact AIreflectionpaper@ema.europa.eu
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 Annual Report 2022
It gives me great pleasure to present to you the European Medicines Agency’s annual report for 2022, which provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU).
The digital report outlines the most important highlights regarding the evaluation and monitoring of human and veterinary medicines and a selection of key figures. It also contains an interactive timeline of important milestones in 2022, with advanced functionalities that allow readers to explore each topic in more depth by accessing additional documents, audio-visual materials and infographics.
Ongoing and newly emerging public health emergencies remained a key focus area of EMA and its partners within the European medicines regulatory network in 2022. Based on EMA’s scientific assessments, new vaccines and treatment options were added to the EU’s arsenal in the fight against COVID-19. When an outbreak of the mpox (monkeypox) virus brought an additional challenge to public health, the crisis preparedness tools established in the context of the Agency’s extended mandate were put to use, ensuring a coordinated EU response. The report includes an overview of EMA’s recommendations on vaccines and treatments for COVID-19 and for mpox. In addition, it highlights the Agency’s activities carried out to implement the EU regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices.
The report also showcases how EMA continued to address public and animal health needs beyond the ongoing public health emergencies. In 2022, EMA recommended the authorisation of 89 medicines for human use, including 41 with a new active substance. Many represented significant progress in their therapeutic areas.
In the area of veterinary medicines, EMA recommended ten medicines for marketing authorisation. On 28 January 2022, the Veterinary Medicinal Products Regulation became applicable, bringing important changes in the regulation of medicines for animals. An overview of these is provided in the report.
EMA’s annual report also draws attention to other major achievements of the Agency, high-impact activities and challenges in 2022. These include the implementation of the Clinical Trials Regulation, which entered into application in January 2022, as well as the successful launches of the Clinical Trials Information System (CTIS) and the Accelerating Clinical Trials in the EU (ACT EU) initiative, which are remodelling the way clinical trials in Europe are initiated, designed and run. Additionally, the report presents EMA’s initiatives aimed at driving transformation in regulatory decision-making by building capability and capacity in the analysis and use of data and real-world evidence.
As in previous editions, the second chapter of the report presents a selection of figures and interesting trends illustrating more broadly the Agency’s activities in the regulation of medicines in the EU. More detailed statistical information about EMA can be found in the print-ready version that is published alongside the digital annual report in PDF format.
I would like to take this opportunity to thank you for your contributions to EMA’s work. The activities and achievements described in this annual report are built on your scientific expertise and passion for public and animal health that you bring to your work at EMA.
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: Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines
On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these medicines. The recommendations address inconsistencies in the product information of veterinary medicines containing NMP, which are marketed in many European Union (EU) Member States. For more details on the CVMP recommendations, please consult the procedure page.
NMP is an excipient used in some veterinary medicines that is classified as a teratogen (a substance that can cause birth defects following exposure during pregnancy) in laboratory animals. There is therefore the possibility that NMP could cause birth defects in children of women who handle or come into contact with NMP-containing medicines during their pregnancy, and in the offspring of animals given these medicines.
More than 1,100 veterinary medicines containing the excipient NMP are available in the EU under various trade names and in different formulations, for use mainly in companion animals and large farm animals. These medicines are available as injections, solutions for infusion, spot-on and pour-on products, shampoos, sheep dips, sprays and concentrates for oral solutions for use in the drinking water of animals or solutions for fish treatment.
The review of veterinary medicines containing NMP is the first referral under Article 82 of Regulation (EU) 2019/6 which was introduced as part of the new EU veterinary medicinal products regulation. The CVMP recommendations were sent to the European Commission, which issued an EU-wide legally binding decision on 28 March 2023.
This communication and related content are published here.
EMA communication: Advancing regulatory science in the EU – mid-point report published
EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas.
“The achievements highlighted in this report demonstrate that we have made considerable progress in advancing regulatory science to build a more adaptive regulatory system that encourages innovation in human and veterinary medicines,” said Emer Cooke, EMA’s Executive Director.
The mid-term report highlights achievements for the top five human and top three veterinary recommendations thought to deliver the most significant change over the course of the five-year strategy, according to an extensive stakeholder consultation process that took place with EMA’s scientific committees, stakeholders and EU regulatory partners.
In the human domain, progress was made in several areas, including:
- fostering innovation in clinical trials;
- promoting use of high-quality, real-world data in decision making;
- reinforcing patient relevance in evidence generation;
- contributing to health technology assessment bodies’ (HTA) preparedness and downstream decision making for innovative medicines;
- supporting developments in precision medicine, biomarkers and ‘omics.
In the veterinary domain, progress was made in several areas, including:
- transforming the regulatory framework for innovative veterinary medicines;
- developing new approaches to improve the benefit-risk assessment of veterinary medicinal products;
- collaborating with stakeholders to modernise veterinary pharmacoepidemiology and pharmacovigilance.
The report also highlights achievements for the human and veterinary medicines strategies. Links are included in the report to detailed information on goals, core recommendations and underlying actions in these areas.
Work will continue at pace through 2023-2025 to deliver the strategic goals to their fullest potential.
A final report on the regulatory science strategy will be published in 2026, once the strategy has been completed.
This communication and related content are published 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.
New EMA video on veterinary medicines
We are pleased to inform you that EMA has launched a video to promote the Veterinary Medicines information website.
Launched in January, the website is a one-stop shop for livestock farmers, pet owners and veterinarians to access up-to-date and reliable information on all authorised veterinary medicines in the EU, enabling them to make informed decisions to protect the health of their animals. Thanks to this new platform, everyone can now easily find out where medicines for animals are authorised and available across Europe. The availability of safety information on these medicines is also highlighted with a reference to the veterinary database.
Share, comment or like our posts on LinkedIn and Twitter and on the joint EU agencies Instagram account (one_healthenv_eu).
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.
