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.
For more information on the European regulatory system for medicines, please click here (brochure available in all languages).
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.
Please note that 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 latest revision (v3) of the Guidance on how to manage clinical trials during the COVID-19 pandemic was published on 28 April. This version contains key changes based also on the feedback from different stakeholders’ groups (patients’ organisations, academia and industry) before and during the drafting process.
In order to provide your Organisation with an overview of the most important elements of this Guidance and the possibility to identify aspects for additional clarification, a webinar will be organised jointly by the European Commission, the European Medicines Agency and the Clinical Trials Facilitation and Coordination Group of HMA with the participation of the drafting team members on 15 May 15.00-17.00.
You will find more information about the webinar by clicking here.
The number of participants will have to be limited for technical reasons and thus early registration is advised by sending a message to: SANTE-PHARMACEUTICALS-B4@ec.europa.eu using “Registration to the webinar on the Guidance on clinical trials during COVID-19” in the subject line.
The link to allow access to the webex conference will be shared with participants later in May. In order to make the information available for broader public, the webex will be recorded and made public on the EMA and Commission website: EUTube.
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.
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.
