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 the following veterinary guidelines and concept papers:
- Qualification opinion on IMI PREFER (15 November 2021)
- Concept paper on scientific guidelines for limited market products deemed not eligible for authorisation under 5 Article 23 of Regulation 2019/6 (15 December 2021)
- Guideline on injection site residue (17 December 2021)
- Guideline on determination of withdrawal periods for milk (17 December 2021)
- Guideline on determination of withdrawal periods for edible tissues (17 December 2021)
- Concept paper on an update to the CVMP’s reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (31 December 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.
EMA: Clinical Trials Information System (CTIS): Virtual information day on 26 October 2021
We would like to inform you that the EMA will host a CTIS virtual information day in liaison with DIA on 26th October 2021 from 13:15 to 17:00 (CET). The aim of the event is to help future CTIS users prepare for submitting and managing clinical trial applications in CTIS after its go-live on 31 January 2022.
This event will present a high-level overview of CTIS via live demonstration of the system's restricted workspaces. It will also present the future user’s perspective on preparing for CTIS go-live, with presentations by future sponsor and Member State users of CTIS. The event will provide ample time for the audience to ask questions.
This event is aimed at clinical trial sponsors and contract research organisations (CROs).
For more information and registration details please see the event webpage. A video recording of the event will be made available on this event page in December 2021.
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.
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.
On behalf of the HMA-EMA joint Big Data Steering Group we are pleased to announce two upcoming stakeholder events.
On 30 November 2021, the Agency will host a webinar on Learnings Initiative for Optimal Use of Big Data.
The objectives of this workshop include to:
· review lessons learned from submissions of real-world data in regulatory applications and discuss future perspectives for big data submission;
· discuss challenges of using innovative methods in the use of big data for regulatory purpose;
· discuss mechanisms for stakeholders’ input on future developments.
On 7 December 2021, the 2nd EU Big Data Stakeholder Forum will take place.
The objectives of this Forum include to:
· inform on current achievements and future plans;
· listen to stakeholders’ views;
· discuss areas for collaboration.
Both events will be held as virtual meetings. To enable wide participation, the events will be broadcast and a recording made public. We anticipate space for a broad representation of stakeholders, and attendance will be organised through EU associations and by direct invitations.
The registration process and the outlines of the agendas’ will be available shortly.
Best wishes,
On behalf of Peter Arlett & Jesper Kjær, Co-chairs Big Data Steering Group
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For related information please refer to: |
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Ivana Silva Public and Stakeholders Engagement Department Stakeholders and Communication Division |
We are delighted to confirm that the SME Veterinary info day titled “EMA's support for SMEs under the new Veterinary Medicinal Products Regulation” will take place on Thursday, 28 October 2021 and will be held as a virtual meeting (https://www.ema.europa.eu/en/events/info-day-micro-small-medium-sized-enterprises-smes-ema-support-smes-under-new-veterinary-medicinal).
The latest programme can be found here.
The info day will provide an overview of EMA initiatives supporting SMEs and service providers operating in the veterinary medicines sector. It will highlight platforms for early dialogue with EMA, the range of support that companies can access to optimise their development plans, and the experience of companies with marketing authorisation applications. The event will also focus on the impact on SMEs of the implementation of the Veterinary Medicinal Products Regulation (EU) 2019/6, which will become applicable on 28 January 2022. It will include demonstrations of the Union Pharmacovigilance Database and of the Union Product Database.
Registration for participation:
Should you wish to attend the SME info day, please click here to pre-register by 13 October 2021, e.o.b. (registration deadline).
Presentations and recordings will be published in the weeks following the event.
SMEs have the opportunity to submit their questions in advance of the meeting. Questions should be sent to sme@ema.europa.eu by 15 October 2021.
For further information please contact the EMA SME Office at SME@ema.europa.eu
The European Medicines Agency has published for public consultation a reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6.
This reflection paper has been developed to provide guidance on when an environmental risk assessment can be requested by competent authorities in the frame of marketing authorisation applications for generic veterinary medicinal products.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 17 December 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 documents on herbal medicines:
- European Union herbal monograph on Agropyron repens (L.) P. Beauv., rhizoma
- List of references supporting the assessment of Agropyron repens (L.) P. Beauv., rhizoma
- Assessment report on Agropyron repens (L.) P. Beauv., rhizoma
- List of references supporting the assessment of Species digestivae
- European Union herbal monograph on Species digestivae
- Assessment report on Species digestivae
Please send your comments to hmpc.secretariat@ema.europa.eu by 31 October 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.
I am pleased to inform you that the European Medicines Agency’s annual report 2020 is now available on the Agency’s website.
The digital report outlines the most important highlights of the evaluation and monitoring of human and veterinary medicines, the European medicines regulatory network’s rapid response to COVID-19, and a high-level overview of key figures. The narrative is complemented by an interactive timeline of EMA’s main activities in 2020 that allows you to explore each topic in more depth, for example through additional audio-visual materials, infographics, videos and documents.
In 2020, EMA and its partners within the European medicines regulatory network had to adapt processes to ensure a rapid response to the COVID-19 pandemic whilst maintaining core regulatory activities to protect public and animal health in the European Union (EU). The report details EMA’s work during the pandemic and highlights key lessons learnt in 2020.
Additional topics covered by the report include the Agency’s response to other public health challenges, such as antimicrobial resistance, and also EMA’s relocation to a new permanent headquarters in Amsterdam, and the preparations for Brexit. The report also describes how the Agency marked its 25th anniversary and explains the steps EMA took to ensure that it is fit to tackle future scientific and technological challenges and take on new responsibilities.
As usual, the second chapter of the report contains core statistics that illustrate the main outcomes of the Agency's regulatory activities, as well as interesting trends and changes observed in recent years. More detailed statistical information about EMA can be found in a traditional print-ready PDF version that is published alongside the digital annual report.
I would like to take this opportunity to thank you for your contributions to EMA’s work. Your input to our initiatives and projects, your willingness to share views and concerns, and your participation in our activities are invaluable to our mission to protect the health or citizens 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 new digital version, please take this survey. Your responses are completely anonymous and will help us improve future editions of the report.
EMA consultation: Veterinary concept papers and guidelines
The European Medicines Agency has published for public consultation the following concept papers and guidelines:
- Concept paper on the development of a guideline on the environmental risk assessment of veterinary medicinal products intended to be used in aquaculture
(Deadline: 31 October 2021)
The Committee for Medicinal Products for Veterinary Use recommends drafting a "Guideline on the environmental risk assessment of veterinary medicinal products intended to be used in aquaculture". The guideline will provide clear guidance on how to perform an ERA for VMPs intended to be used in aquaculture. The impact of the guideline for industry, regulatory authorities and other interested parties is therefore considered to be high, as it will reduce the current regulatory uncertainty and disharmonisation while simultaneously ensuring an increase of public and animal health/welfare as well as environmental protection.
- Guideline on clinical trials with immunological veterinary medicinal products - (Deadline: 29 October 2021)
The main aim of the guideline is to advise on how to perform clinical trials (also called field trials) with immunological veterinary medicinal products (IVMPs) and to address the requirements of the Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council regarding clinical trials for IVMPs.
In addition, guidance is provided on when omission of clinical efficacy data may be acceptable.
This guideline replaces the Note for Guidance ‘Field trials with veterinary vaccines’ (EMEA/CVMP/852799-Final).
- Guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances - (Deadline: 29 October 2021)
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 introduces specific provisions for applications under exceptional circumstances (Article 25).
The general aim of this guideline is to define minimum data requirements for the demonstration of quality, safety and efficacy of immunological veterinary medicinal products (IVMPs) for applications submitted under Article 25 of Regulation (EU) 2019/6.
It is the intention of the guideline to provide comprehensive guidance on the essential requirements for such applications.
A summary of possible reductions in data requirements for applications for IVMPs under exceptional 47 circumstances is presented in the Annex of this guideline.
- Guideline on data requirements for vaccine platform technology master files (vPTMF) - (Deadline: 29 October 2021)
The main aim of the guideline is to address the type of data to be included in a vaccine platform technology master file (vPTMF). Furthermore, the guideline addresses the omission of information and /or possible reductions on data requirements for subsequent dossier submissions for marketing authorisations (MA) based on a vPTMF after its first evaluation and certification.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by the indicated deadlines.
EMA communication: Use of antibiotics in animals is decreasing
We would like inform you of the latest report published by the European Food Safety Authority (EFSA), the European Medicines Agency and the European Centre for Disease Prevention and Control (ECDC), which says that the use of antibiotics has decreased and is now lower in food-producing animals than in humans.
Taking a One Health approach, the report from the three EU agencies presents data on antibiotic consumption and development of antimicrobial resistance (AMR) in Europe for 2016-2018.
The significant fall in antibiotic use in food-producing animals suggests that the measures taken at country level to reduce use are proving to be effective. Use of a class of antibiotics called polymyxins, which includes colistin, nearly halved between 2016 and 2018 in food-producing animals. This is a positive development, as polymyxins are also used in hospitals to treat patients infected with multidrug-resistant bacteria.
The picture in the EU is diverse – the situation varies significantly by country and by antibiotic class. For example, aminopenicillins, 3rd- and 4th-generation cephalosporins and quinolones (fluoroquinolones and other quinolones) are used more in humans than in food-producing animals, while polymyxins (colistin) and tetracyclines are used more in food-producing animals than in humans.
The link between use of antibiotics and bacterial resistance
The report shows that the use of carbapenems, 3rd- and 4th-generation cephalosporins and quinolones in humans is associated with resistance to these antibiotics in Escherichia coli infections in humans. Similar associations were found for food-producing animals.
The report also identifies links between antimicrobial consumption in animals and AMR in bacteria from food-producing animals, which in turn is associated with AMR in bacteria from humans. An example of this is Campylobacter spp. bacteria, which are found in food producing animals and cause foodborne infections in humans. Experts found an association between resistance in these bacteria in animals and resistance in the same bacteria in humans.
For more related content, please click here.
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.
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) has developed 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.
