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 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.
The European Medicines Agency has published, for public consultation, six modules of the draft guideline on veterinary good pharmacovigilance practices (VGVP):
- Veterinary pharmacovigilance communication
- Signal management
- Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files
- Glossary
- Controls and pharmacovigilance inspections
- Collection and recording of suspected adverse events for veterinary medicinal products
Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu by 5 September 2021.
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.
The European Medicines Agency has published for public consultation the following veterinary concept papers and guidelines:
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC entered into force on 28 January 2019 and is applicable from 28 January 2022 onwards. Article 4 of this regulation introduces a new definition for withdrawal period (WP), differing from the definition currently used in residues guidelines. This new definition triggers a revision of the relevant residues guidelines.
Deadline for comments: 31 July 2021
The main aim of the guideline is to address the data to be included in a vaccine antigen master file (VAMF) for veterinary vaccines. Guidance is provided on the data for active substances (antigens) to be included in a VAMF. The guideline includes scientific requirements for the submission, the evaluation and certification of VAMFs.
Deadline for comments: 30 September 2021
Rev. 1 of the guideline provided information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). Rev. 2 outlines important items related to the quality, safety and efficacy parts of the marketing authorisation dossier that were not sufficiently defined in the requirements of Annex I of Directive 2001/82/EC and the European Pharmacopoeia.
Deadline for comments: 30 September 2021
The main aim of the guideline is to address the use of a multi-strain dossier for inactivated vaccines against antigenically variable viruses or bacteria and to provide information on criteria for eligibility to use the multi-strain approach and on data to be included in a multi-strain dossier. Due to the extension of the multi-strain approach to viral diseases in addition to avian influenza (AI), bluetongue (BT) and foot-and-mouth disease (FMD) and to bacterial diseases requiring a need for rapid or frequent change in the strains included in the final product, a revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against AI, BT and FMD was necessary.
Deadline for comments: 30 September 2021
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by the indicated deadline.
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.
We would like to share with you our recent communications on COVID-19 vaccines as at 22nd June 2021:
COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality
COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis
EMA advises against use in people with history of capillary leak syndrome
EMA evaluating the use of COVID-19 Vaccine Moderna in young people aged 12 to 17
Using real-world data to monitor Covid-19 vaccines in Europe: joint EMA/ECDC initiative
Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine
International regulators and WHO address need to boost COVID-19 vaccine confidence
All the latest updates on COVID-19 vaccines and treatments are available by clicking here.
We also take this opportunity to highlight our new webpage on Website outages and upgrades, where you can see when our website will be unavailable and find a list of the main improvements made during previous upgrades.
The European Medicines Agency has published for public consultation the following documents on herbal medicines:
- European Union herbal monograph on Trigonella foenum-graecum , semen
- European Union herbal monograph on Hypericum perforatum L., herba, (traditional use) – 2nd draft – revision 1
- Assessment report on Hypericum perforatum , herba - 2nd Draft – Revision 1
- List of references supporting the assessment of Hypericum perforatum L., herba - 2nd Draft – Revision 1
Deadline for comments: 15 July 2021.
- Public statement on Saccharomyces cerevisiae CBS 5926 - Draft
- European Union herbal monograph on Taraxacum officinale H. Wigg., radix - Draft
- European Union herbal monograph on Vaccinium macrocarpon Aiton, fructus - Draft
Deadline for comments: 31 August 2021.
Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.
The European Medicines Agency has published for public consultation a draft EU VICH adverse event report implementation guide.
This document aims to support stakeholders in the implementation of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC1 (‘the Regulation’), by providing guidance on the technical specifications and the process of transmission of adverse event reports (AERs). It is targeted at all stakeholders responsible for submitting AERs electronically to the Union Pharmacovigilance Database.
Comments should be provided using this template and sent to vetchange.programme@ema.europa.eu by 4 August 2021.
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.
The European Medicines Agency has published for public consultation a reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products.
This reflection paper provides guidance on the cells and methods to be used for the detection of extraneous agents of the veterinary immunological medicinal products and biological origin materials used in their production.
Comments should be provided using this template and sent to Vet-guidelines@ema.europa.eu by 23 July 2021.
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.
We are pleased to share with you the latest edition of the Veterinary Medicines Regulation Highlights, which provides updates on the progress at the Agency towards implementing Regulation (EU) 2019/6.
The Newsletter is published every two months.
You can access the Newsletter by clicking here. Previous editions can be found on this page.
Should you have any question, please do not hesitate to contact EMA’s Veterinary Medicinal Products Regulation Programme at vetchange.programme@ema.europa.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.
Highlight actions of 2021:
- Development of the EMA Regulatory Science Research Agenda
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.
Clinical Trials Information System reaches major milestone towards go-live and application of the Clinical Trial Regulation
On 21 April 2021, the EMA Management Board during its extraordinary meeting confirmed that it has verified that the clinical trial EU Portal and Database meets the agreed requirements following an independent audit of this new IT system.
We would like to take this opportunity to thank everyone involved for their continued support in this development as we work together now to ensure a successful go-live and implementation of the Clinical Trial Regulation. Your valuable contribution throughout the years has enabled us to achieve this major milestone and we are looking forward to continuing our close and fruitful collaboration.
As a next step, the Board will inform the European Commission of this outcome. Once satisfied that the conditions set by the Clinical Trial Regulation have been met, the European Commission will publish a notice in the Official Journal of the European Union and six months after this publication, the Clinical Trial Regulation will start to apply and CTIS will go live. It is the desire of the Board, EMA and European Commission that the system goes live on 31 January 2022, which would imply that the Commission notice in the Official Journal would be published on 31 July 2021.
For further details, please see the news published on our website:
EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for the next five years, following its recent adoption by the HMA and EMA Management Board.
The strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.
“The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” said Emer Cooke, EMA’s Executive Director. “Lack of availability of medicines, either because they are not marketed or due to supply disruptions, has shown to pose serious threats to patient and animal health, animal disease control programs and sustainable livestock production. This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”
The European medicines agencies network strategy to 2025 outlines six priority areas for the network:
- the availability and accessibility of medicines;
- data analytics, digital tools and digital transformation;
- innovation;
- antimicrobial resistance and other emerging health threats;
- supply chain challenges; and
- the sustainability of the network and operational excellence.
The network will review the strategy after 18 months to consider if the goals and objectives remain appropriate, and to adjust them if necessary, in the light of the changing environment and ongoing engagement with stakeholders.
For more details and related content please click here.
The European Medicines Agency (EMA) is developing a secure online platform for submitting and managing scientific advice applications. From 19 October 2020, EMA will require scientific advice applicants to use the IRIS | Regulatory & Scientific Information Management Platform to manage scientific advice processes with EMA. The below described procedures are intended for future academics applying for Scientific Advice and concern:
- Human domain: Initial and Follow-up Scientific Advice, Initial and Follow-up Protocol Assistance, Initial and Follow-up Qualification Procedure
- Veterinary domain: Initial and Follow-up Scientific Advice
IRIS will provide a single space for applicants to submit and manage information and documents related to their scientific advice applications. This is expected to reduce the time needed to prepare and submit applications and ensure better data quality through integration with other EMA systems. It will allow applicants to check the status of their applications from any device, and to receive automatic status-update notifications.
To begin using the platform from 19 October 2020, it is extremely important that scientific advice applicants follow these preparatory activities in advance of the launch.
Registration steps
Please complete the registration steps below before attempting to carry out any activity relating to scientific advice using the IRIS platform. You may find it helpful to refer to the quick interactive guide to IRIS registration process which provides a summary of registration actions in order to ensure that:
- You have an active EMA account.
- Your organisation is registered in EMA’s Organisation Management Service (OMS). It can take from five to ten working days to update or register a new organisation.
- You have the appropriate user access role and affiliation to an organisation. IRIS user roles are requested in the EMA Account Management portal .
To be able to submit your scientific application via IRIS you will also need to ensure that:
- You have a valid EMA customer account number, which is a unique reference number for financial matters required to submit scientific advice applications.
- You have a valid Research Product Identifier (RPI) that EMA uses to track medicines through pre-authorisation procedures. Requests for new RPIs, including requests for transfers of RPIs, are submitted via IRIS. In cases, where a request for RPI also requires registration of an active substance in the EMA’s public list of substances this may take up to five working days.
IRIS registration steps are explained in detail in the IRIS guide to registration.
For further questions, please contact the IRIS project team at iris@ema.europa.eu
We would like to inform you that the Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan which sets actions to be delivered in 2020-21. With the European Medicines Regulatory Network focused on the response to the COVID-19 pandemic, the workplan aims to progress evolution to data-driven regulation through smart working, leveraging collaboration with stakeholders and the use of remote expert workshops.
In the past three years, EMA and HMA have led a thorough assessment of the challenges and opportunities posed by big data in medicines regulation. This culminated in January 2020 with the publication of recommendations for regulators to evolve their approach to data use and evidence generation.
Following this preparatory work, the Big Data Steering Group was established in February 2020 to advise the EMA Management Board and HMA on implementing ten priority recommendations.
Its first workplan, published today, aims to increase the utility of big data in regulation from the quality of data through study methods to assessment and decision-making. It foresees closely involving patients and is guided by advances in science and technology. Other stakeholders will also be involved and the workplan intends to leverage international collaboration. Stakeholders will have the opportunity to discuss the workplan and its implementation in the context of a virtual multi-stakeholder forum scheduled for late 2020.
Big data are extremely large, rapidly accumulating datasets captured across multiple settings and devices, for example through wearable devices and electronic health records. Coupled to rapidly developing technology, big data can complement the evidence from clinical trials and fill knowledge gaps on a medicine, and help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The rapidly changing data landscape forces regulators to evolve and change the way they access, manage and analyse data and to keep pace with the rapid advances in science and technology.
The work carried out by the Big Data Steering Group builds on the Regulatory Science Strategy to 2025, published in March 2020, and will support the European Medicines Agencies Network Strategy to 2025, currently under development.
The European Medicines Regulatory Network has to prioritise the unprecedented public health challenge of the COVID-19 pandemic and implementation of the Big Data Steering Group workplan will need to be flexible and certain actions may need to be re-scheduled depending on the development of the pandemic.
For more information on big data, 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.
The EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022.
On this webpage, stakeholders can find all relevant information regarding EMA’s scientific and technical recommendations to the European Commission that will feed into delegated and implementing acts as part of the implementation of the legislation, as well as updates on other activities such as the preparation for implementation progresses.
The new regulation contains new measures for increasing the availability of veterinary medicines and enhances EU action against antimicrobial resistance, a high priority for the Agency and the European medicines regulatory network. It also aims to reduce administrative burden and encourage medicine innovation and development.
For more details, please click here.
