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.
EMA veterinary medicines info day 2022 on 12-13 May 2022
We are pleased to inform you that the EMA is organising a virtual Veterinary Medicines Info Day 2022 on 12 and 13 May 2022.
The webinar will provide updates on topics related with regulatory policy, scientific and procedural developments resulting from the Veterinary Medicinal Products Regulation (EU) 2019/6.
The Regulation (EU) 2019/6 became applicable on 28 January 2022, together with establishment at EU-level of databases to support the implementation of the new or changed legislative requirements, to reduce administrative burden and to improve the transparency of information on the safety and efficacy of veterinary medicinal products in the European Union.
The event will also provide the opportunity for participants to ask any questions.
For more details, please find attached the draft programme. The final agenda will be available on the event page.
Please note that registration is mandatory to attend the webinar. If you wish to participate, please register by 10 May 2022 for each day using the online form provided on the event page.
A video recording of the Info Day will be available after the event.
For any additional information about this event, please send an email to: vetchange.programme@ema.europa.eu.
EMA Consultation: Call for scientific data for the periodic review of herbal monographs
The Committee on Herbal Medicinal Products (HMPC) invites all interested parties to submit any scientific data that the HMPC should consider at the periodic review of the 8 monographs listed below towards a possible revision of the monographs and its supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date:
Scientific contributions should be sent by email to hmpc.secretariat@ema.europa.eu by 14 July 2022.
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 Consultation: Call for scientific data for the periodic review of herbal monographs
The Committee on Herbal Medicinal Products (HMPC) invites all interested parties to submit any scientific data that the HMPC should consider at the periodic review of the 8 monographs listed below towards a possible revision of the monographs and its supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date:
Scientific contributions should be sent by email to hmpc.secretariat@ema.europa.eu by 14 June 2022.
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 communication: Regulation on EMA’s extended mandate becomes applicable
The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes applicable as of today, 1 March 2022. It puts some of the structures and processes established by EMA during the COVID-19 pandemic on a more permanent footing, while entrusting several new tasks to the Agency.
EMA is now responsible for monitoring medicine shortages that might lead to a crisis situation, as well as reporting shortages of critical medicines during a crisis. The Agency will also coordinate responses of EU / EEA countries to shortages of critical medical devices and in-vitro diagnostics in crisis situations, after an initial transition period up to 2 February 2023.
Over the next few weeks and months, EMA will set up a number of new bodies and formalise existing ones to manage the new tasks.
In preparation for the application of the new regulation, EMA has set up the permanent secretariat to support 12 medical device expert panels established by the Medical Devices Regulation in order to improve the safety of medical devices marketed in the EU / EEA. The expert panels, previously managed by the Commission’s Joint Research Centre, provide opinions and views to notified bodies on the scientific assessment of clinical and performance evaluations of certain high-risk medical devices and in-vitro diagnostics.
In addition, in order to ensure a robust response to major events in relation to shortages, the legislation establishes an Executive Steering Group on Shortages and Safety of Medicinal Products (also known as the Medicines Shortages Steering Group, MSSG).
The Emergency Task Force (ETF) is expected to start operating under the new rules from mid-April. Its responsibilities include: providing scientific advice on the development of products intended for use during a public health emergency, reviewing scientific data, providing recommendations on the use of unauthorised medicines, and coordinating independent vaccine effectiveness and safety monitoring studies. The composition and Rules of Procedure of the MSSG and ETF will be considered for endorsement by EMA’s Management Board in March.
Other key milestones planned for the coming weeks and months include: updating the role of the EU Single Point of Contact (SPOC) network, a system that EMA and national competent authorities use to exchange information on shortages. Under the new mandate, the SPOC will support the MSSG and provide recommendations on all matters relating to monitoring and management of shortages and availability issues during a crisis, as well as outside crisis situations; providing guidance to companies on the industry SPOC (i-SPOC) network; updating EMA’s plan for Emerging Health Threats; establishing a list of the main therapeutic groups of medicines necessary for emergency care, surgeries and intensive care, to help prepare the lists of critical medicines to respond to public health emergencies or major events.
EMA is organising a workshop on 1 April to inform stakeholders of its extended mandate and explain the plans and timelines for its implementation, and to listen to stakeholders’ views and any concerns. The workshop will be broadcast live on EMA’s website.
This announcement and related content are available here.
EMA consultation: Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6
The European Medicines Agency has published for public consultation the “Reflection paper on criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6”.
Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances are associated with specific concerns because of their persistence, their ability to accumulate in the environment and in living organisms, as well as their toxicity. Due to the combination of these intrinsic properties and possible redistribution across environmental compartments, PBT/vPvB substances can give rise to toxic effects over a longer time and a greater spatial scale than substances without these properties. The effects of persistence/bioaccumulation are unpredictable in the long-term. In the case of vPvB substances specifically, even if limited toxicity is demonstrated in laboratory testing, there is a concern that long-term effects may be possible since, over time, high concentrations may be reached in the environment or in animals at the top of the food chain.
The purpose of this reflection paper is to establish criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6.
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 31 May 2022.
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.
Start of review concerning veterinary medicines containing procaine benzylpenicillin
EMA has started a review of veterinary medicines containing procaine benzylpenicillin as a single active substance presented as suspensions for injection.
These medicines have been used widely throughout the EU for decades. It has been noticed that the authorised durations of treatment vary between the different products and based on available data not all of them might be appropriate to treat all claimed indications effectively. This could also lead to a risk of development of antimicrobial resistance.
Having considered this issue, the national veterinary medicines regulatory authority of Germany requested EMA’s veterinary medicines committee (CVMP) to assess its impact on the benefits and risks of veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection (link).
In accordance with Article 83(1) of Regulation (EU) 2019/6, all interested parties are invited to submit information relevant to the procedure, addressing the Committee for Veterinary Medicinal Products (CVMP) list of questions by 9 September 2022 using this form.
All documents related to this procedure are available here.
EMA Consultation: Call for scientific data for the periodic review of herbal monographs
The Committee on Herbal Medicinal Products (HMPC) invites all interested parties to submit any scientific data that the HMPC should consider at the periodic review of the 8 monographs listed below towards a possible revision of the monographs and its supporting documents. The publication of this call is the first step in the procedure established by the committee so that adopted monographs remain up-to-date:
- Matricariae flos
- Helichrysi flos
- Ginkgo folium
- Eschscholziae herba
- Epilobii herba
- Crataegi folium cum flore
- Capsici fructus
Scientific contributions should be sent by email to hmpc.secretariat@ema.europa.eu by 14 May 2022.
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 communication: First issue of the Big Data Highlights
We are pleased to send you the first issue of the Big Data Highlights which reports on the implementation of the HMA-EMA Big Data Steering Group workplan 2021-2023 and the data and digital pillar of the Network Strategy 2025.
You can subscribe to this quarterly newsletter by sending an email to bigdata@ema.europa.eu.
For more information on big data, please consult our dedicated webpage.
EMA consultation: Veterinary concept papers and guidelines
The European Medicines Agency has published, for public consultation, the following veterinary paper:
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.
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.
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 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.
