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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.
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.
We would like to give you advance notice of an upcoming virtual veterinary workshop organised to discuss any written comments received during the public consultation on the concept paper for the development of a reflection paper on criteria for the application of Article 40(5) of Regulation (EU) 2019/6.
The virtual workshop will be held on 15 October 2020 from 13:30 to 16:30 CET.
It will be chaired by Barbara Freischem, EMA Head of Department for Surveillance and Regulatory Support, with the participation of:
· The Committee for Medicinal Products for Veterinary Use (CVMP) drafting group on criteria for the application of Article 40(5) of Regulation (EU) 2019/6, which is composed of the CVMP Vice-Chair, several CVMP Working Party Chairs, a CVMP member and the Chair of the Co-ordination for Group for Mutual Recognition and Decentralised Procedure - Veterinary (CMDv);
- Supporting scientific experts for the specific topics of antimicrobial and antiparasitic resistance;
- EMA secretariat.
An outline agenda and details on registration process will be sent in due course before the meeting.
The European Medicines Agency has published for public consultation a “public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with pyrrolizidine alkaloids”.
It became apparent during assessment of Symphytum officinale that the risk assessment of pyrrolizidine alkaloids (PAs) poses considerable difficulties, with several PAs being regarded as both hepatotoxic and carcinogenic. Considering that Pas are natural constituents of a number of plants used for medicinal purposes the HMPC decided to prepare a public statement on the use of herbal preparations containing PAs.
Furthermore, it was increasingly reported that herbal teas including those used as medicines may contain variable amounts of PAs, although the plants used as ingredients are not known to produce PAs. In the following, based on information from several Member States, it was recognised that there might be a problem of contamination due to PA-containing weeds, which has to be seen primarily as quality-related topic. Several national regulatory authorities addressed the issue of PA contamination in HMPs and also the HMPC prepared a statement to support harmonisation in this regard. The Public statement on contamination of herbal medicinal products/traditional herbal medicinal products with pyrrolizidine alkaloids gave transitional recommendations for risk management and quality control.
After a 3-years-period, the HMPC decided to reconsider both Public statements and published Calls for data before re-assessing and concluding on recommendations with respect to the risks associated with the use of herbal medicinal products containing PAs naturally or from contamination.
Revision 1 is based on a review of newly available data and the improved evaluation methods. The specific contamination issue and subsequent recommendations for risk management and quality control are now included.
Deadline for comments: 15 November 2020.
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).
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 email@example.com 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.
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.
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.
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.