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).
The European Medicines Agency is carrying out a survey to assess how our communications to the general public are perceived and valued by our stakeholders. This will provide valuable feedback to help us to better plan and carry out our communication activities. This is the third communications survey, the previous ones having taken place in 2015 and 2017. This exercise is repeated every 2-3 years.
The survey focuses on EMA communication activities to the general public (i.e. EMA information made public mainly through the EMA website such as press releases and news announcements). It does NOT relate to communication as part of your regular or professional interaction with EMA (e.g. communications with EMA officials in the context of an evaluation procedure or any other information exchange under working arrangements).
Your vital perspective will help to shape our future communication activities. Once available, EMA will share the results of the analysis with you.
An electronic link to the survey is included below. The survey will be open for five weeks, until 13 September 2020, for you to respond.
https://ec.europa.eu/eusurvey/runner/perceptionsurvey2020
Please note that in this survey EMA does not collect or process personal data. Therefore, please make sure that you do not reveal your identity in the free text answers. The survey is designed to collect the answers only in an aggregated and anonymous format. The responses will only be evaluated in an aggregated way and the results will be shared in such format as well. As regards the processing of your data by the EUSurvey application, please refer to the specific privacy statement of the EUSurvey tool: https://ec.europa.eu/eusurvey/home/privacystatement
Thank you very much in advance for your time and your contribution to this important exercise. Should you need any further information or clarification, please do not hesitate to contact Ms Elena Dimitrova (Elena.Dimitrova@ema.europa.eu).
The European Medicines Agency has published for public consultation for a concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6.
The purpose of the reflection paper would be to explore and reflect on the state of knowledge in the fields addressed by Article 40(5), particularly as regards criteria demonstrating a reduction of resistance, as a preliminary step towards an eventual guideline. Types of product development falling within the scope of Article 40(5) that could meet the criterion of improving the benefit-risk balance of the veterinary medicinal product will also be considered. The reflection paper will further consider whether any existing guidance would benefit from being updated due to the provisions of Article 40(5).
Comments should be provided using this template and sent to Vet-guidelines@ema.europa.eu by 21 September 2020.
We are pleased to send you the first edition of the Veterinary Medicines Regulation Highlights which includes an update on the preparations for the implementation of Regulation (EU) 2019/6.
For more information on veterinary medicines regulatory information, please click here.
The European Medicines Agency has published for public consultation on a draft access policy: Union Product Database Access Policy (UPD) - Veterinary Medicinal Products.
Veterinary stakeholders are invited to comment on a draft access policy for the Union Product Database, which will provide information on all authorised veterinary medicines and their availability in EU Member States. The access policy sets out the types of information different user groups should be allowed to access once the database becomes operational in January 2022.
Implementation of the Union Product Database is required by the new Veterinary Medicines Regulation. For more information, see Implementation of the new Veterinary Medicines Regulation.
Stakeholders should submit comments on the access policy to vetchange.programme@ema.europa.eu by 18 September 2020.
The European Medicines Agency has published for public consultation the Committee for Medicinal Products for Veterinary Use (CVMP) strategy on antimicrobials 2021-2025
It is estimated that in 2015 there were more than 670,000 human infections with antibiotic-resistant bacteria in the EU/EEA and that these accounted for 33,000 deaths, according to a study based on data from the European Antimicrobial Resistance Network. The European One Health Action Plan against antimicrobial resistance (AMR) acknowledges this serious social and economic burden and provides a framework of concrete actions.
Considering the CVMP’s regulatory responsibility to ensure the safety and efficacy of antimicrobial veterinary medicines and to provide scientific advice to the Commission on AMR, many of the CVMP’s activities proposed for the next five years focus on assisting with the effective implementation of the new legislation to ensure it achieves its objective to strengthen the EU’s actions in the fight against AMR. Related tasks have already started in 2020, building on foundations laid down by CVMP whilst fulfilling its preceding strategies on antimicrobials. An overview of the activities undertaken by CVMP in 2016-2020 is presented in this document.
Comments should be provided using this template and sent to Vet-guidelines@ema.europa.eu by 30 September 2020.
EMA and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years that is released for a two-month public consultation today. The draft strategy details how the European medicines agencies’ 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 European Medicines Agencies Network Strategy to 2025, which builds on the HMA/EMA strategy to 2020, 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.
It identifies high-level goals and supporting recommendations for each of these areas, which will guide and shape the detailed work plans of EMA and the national competent authorities in EU Member States in the coming five years.
Input on the draft strategy document is welcome from all stakeholders, including members of the public, until 4 September 2020 via an online questionnaire.
By participating to the survey, the submissions will be assessed by EMA and HMA. EMA collects and stores the personal data of stakeholders and interested parties who submit contributions for the purpose of this survey. Requests for contributions to be published in an anonymised form, can be sent to the data controller (S-DataController@ema.europa.eu).
For more information and related content, please click here.
EMA and its partners in the European medicines regulatory network are closely monitoring the potential impact of the outbreak of the novel coronavirus disease (COVID-19) on pharmaceutical supply chains into the European Union (EU). No reports of current shortages or supply disruptions of medicines marketed in the EU due to this outbreak have been received at this point. As the public health emergency develops, shortages or disruptions cannot be excluded.
The EU (EMA, the European Commission and national competent authorities in the Member States) have organised the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events to discuss measures aimed at addressing the impact of the outbreak of COVID-19 on the supply of medicines in the EU. The mandate of this group is to provide strategic leadership for urgent and coordinated action within the EU in case a crisis caused by major events, such as the COVID-19 outbreak, risks impacting the supply of medicinal products for human and veterinary use.
In the context of COVID-19, the group will identify and coordinate EU-wide actions to protect patients when medicines in the EU are at risk of supply shortage, e.g. due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment. The group will also ensure that patients and healthcare professionals across the EU are kept informed in a consistent and transparent manner about the risks and the remedial actions taken.
For more information on the EU Executive Steering Group and the actions already taken, 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 European Medicines Agency has released for public consultation a concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals.
The purpose of a future reflection paper would be to research and reflect on the state of knowledge on the emission into the environment of veterinary medicines containing parasiticides that are used in companion animals and on measured and modelled concentrations. The paper would address the potential risks for the environment due to the use of veterinary medicines used in companion animals, reflect on the current assumptions for exposure pathways and overall environmental exposure considerations, also exploring the need and feasibility of mitigation measures. It will also consider whether the current VICH evaluation framework remains appropriate for all type of products used in companion animals, and reflect on possible monitoring options that could be considered for relevant substances (e.g. those that are used under more than one regulatory framework, for instance VMPs and plant protection products) .
The draft paper is available by clicking here.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 October 2020.
Advancing regulatory science in the EU – new strategy adopted
On 31st March 2020 the EMA published its Regulatory Science Strategy to 2025. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic acceleration of the pace of innovation in recent years and the need for regulators to be ready to support the development of increasingly complex human and veterinary medicines that combine different technologies.
The ongoing COVID-19 pandemic underlines the need for rapid and close engagement of all stakeholders and partners involved in the development and supervision of medicines in the European Union and globally, which is one of the fundamental principles of this strategy. The learnings from the handling of this public health crisis will be incorporated so that we can adapt our process in real-time, where needed.
The strategy sets out key areas where new or enhanced engagement of the European medicines regulatory network is essential and where advances in regulatory science are necessary.
The document identifies strategic goals for such engagement for human and veterinary medicines and proposes core recommendations and underlying actions to support these.
For the press release and related content, please click here.
The European Medicines Agency has published the “Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use”.
This guideline has been revised and provides new text to be included in the package leaflet of medicines containing ethanol as excipient. It contains more detailed information on the effects of ethanol when used as excipient, in particular on babies and children.
This document is the Annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use. It contains the information which should appear in the package leaflet for the excipients known to have a recognised action or effect. The annex is effective from 22 November 2019.
For already authorised medicines, marketing authorisation holders should use the first opportunity to implement the wording in compliance with the revised annex.
For medicines with no foreseeable regulatory submissions, marketing authorisation holders should submit a type IB variation within 3 years after the publication of the revised annex
Please find a link to additional information on the Annex. The rational for revising information on ethanol, which went through public consultation, has also been published: Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use.
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.
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.
