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.
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 communication: Latest updates on COVID-19 vaccines as at 26th April 2021
We would like to share with you our recent communications on COVID-19 vaccines:
· 02 Public Safety Update_COVID-19 VACCINE JANSSEN_22 April 2021
· EMA starts review of VIR-7831 for treating patients with COVID-19
· AstraZeneca’s COVID-19 vaccine: benefits and risks in context
· EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
All the latest updates on COVID-19 vaccines and treatments are available by clicking 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:
We are pleased to inform you that the registration for the Veterinary Big Data Stakeholder Forum is now open. The event taking place on 1 and 2 June will be hosted virtually on Webex. Please register by 25 May 2021. If you want to participate both on 1 and 2 June, please register for both dates via the Webex links below.
- 1 June 2021: registration link
- 2 June 2021: registration link
.
The draft agenda is available on EMA’s website. We aim at publishing the final agenda in due course. Please feel free to disseminate the registration link to interested colleagues. Participation is free of charge.
If you want to be directly notified, please indicate your interest at vet-bigdata@ema.europa.eu.
In the context of the Big Data initiative’s 10 priority recommendations, the HMA/EMA Big Data Steering Group is developing a Data Standards Strategy, which will enable the Network to more effectively leverage data to deliver evidence in support of benefit-risk decision-making on the development, authorisation and use of medicines for human and veterinary use. The plan is to consult with a wide range of stakeholders from Human and Veterinary domains to better understand data standardisation needs related to the submission, receipt and (re-)use of scientific data at each stage of the lifecycle of medicinal products. As preliminary consultation, an online survey is hereby shared with veterinary stakeholders to collect initial needs and priorities. All these preliminary inputs will inform the draft Data Standards Strategy document and will be discussed during a virtual workshop on 18 of May 2021.
It is important to note, that inputs received via this survey and the draft Data Standards Strategy will be considered as a first reflection on veterinary needs and opportunities. They will be further expanded as the implementation of the veterinary medicinal products regulation progresses throughout 2021 and discussed in-depth at the upcoming Veterinary big Data Stakeholder Forum on 1 and 2 June event that will bring together all stakeholders interested in data-driven activities in the veterinary regulatory environment. Hence any current inputs on veterinary needs and opportunities on Data Standards will build upon the processes, formats and solutions that are currently under development in the frame of the veterinary medicinal products regulation implementation and will be reflected in the EU Veterinary Big Data Strategy aligning with ongoing projects related to standardisation of data submissions and publication in which you may already be involved (examples: ISO IDMP, ePI, eCTD).
We would kindly ask you to provide us with the following information by the 7th of May close of business:
- A single survey contribution from your organisation: You will find attached a PDF document including the survey questions for ease of reference. In addition, here is the link to the online survey (to be open in Google Chrome): LINK. We would be grateful if a designated person could centralise and consolidate the responses from your members before completing the survey.
- The names and contact details of up to 3 representatives (experts in the field of data standardisation/use, where possible) for each interested organisation to participate in the Data Standards workshop on 18 May 2021. The number of participants in the virtual room is limited to ensure a smooth running of the virtual meeting.
Note that the workshop will be broadcast live to provide the opportunity for any additional interested colleagues to listen to the discussions.
Should you have any questions, please do not hesitate to contact us at: DataStandardsStrategy@ema.europa.eu and vet-bigdata@ema.europa.eu
We also take the opportunity to inform you that registration for the Veterinary Big Data Stakeholder Forum to be held on 1 and 2 June is now open. Information on how to register is available at this link.
EMA Consultation: Call for scientific data for 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 eight herbal monographs 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.
- Marrubii herba
- Urticae radix
- Lichen islandicus
- Liquiritiae radix
- Origani dictamni herba
- Paulliniae semen
- Rhodiolae roseae rhizoma et radix
- Tiliae flos
Deadline for comments: 30 June 2021.
Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.
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: Draft QRD veterinary annotated product information template v.9
A draft QRD veterinary annotated product information template v.9 is available in draft for public consultation, intended to take account of the requirements of the Veterinary Medicines Regulation (Regulation (EU) 2019/6).
EMA and the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) will inform marketing authorisation applicants and holders when to start using the new template, after Regulation (EU) 2019/6 enters into force in January 2022.
The new template contains:
- a new structure of the SPC and package leaflet;
- information only to be included in the package leaflet that was formerly in the labelling, to simplify the outer and immediate labelling and emphasise the importance of reading the package leaflet;
- a consolidated section on ‘minimum particulars to appear on small immediate packaging units' which now incorporates blisters and strips;
- a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines, to limit the risk of development of Antimicrobial resistance;
- standard text for marketing authorisations granted for veterinary limited markets and under exceptional circumstances;
- reference to national collection systems for disposal of waste veterinary medicines;
- guidance on specific content for novel therapies.
EMA also simplified the SPC and package leaflet sections on 'frequency and seriousness of adverse events', based on advice from the CVMP's Pharmacovigilance Working Party, and aligned the sequence of package leaflet sections with the SPC as far as possible.
The template contains a high-level cross-reference to all relevant guidance and legislation (see lines 39-41) rather than references to specific guidance in different sections, as some legal acts and guidance are under development.
EMA is not publishing the new template with tracked changes as these would be visually difficult to read and it is simpler to compare the clean text with the current template.
Stakeholders are invited to send their comments to qrd@ema.europa.eu using this template by 14 May 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.
Please note that the Agency has decided to extend the due date for submission of offers to Friday 30 April 2021 at 12:00 (noon) CET.
The new due date for submission of questions is Wednesday 21 April 2021 cob. The extension will be made public in a corrigendum, which will be published in the Official Journal of the EU in due course. The due date for submission of offers will be amended in e-Submission as soon as the corrigendum has been published in the Official Journal of the EU.
The European Medicines Agency has published today a call for tenders for the Quality, Efficacy and Safety Studies on Medicines.
The purpose of this Call is to purchase the services of research organisations to perform pre- and post-authorisation quality, efficacy and safety research to generate data and information to support regulatory decision-making for human and veterinary medicinal products. As compared to the previous Calls, the scope of studies that might be contracted to organisations selected through this Call has been extended to:
- Lot 1: Pre-clinical research
- Lot 2: Veterinary studies
- Lot 3: Statistical research
- Lot 4: Qualitative research
- Lot 5: Pharmacoepidemiological research
- Lot 6: Quality of medicines
All information related to this call are available by clicking here: https://etendering.ted.europa.eu/cft/cft-display.html?cftId=7933.
Organisations may apply for one or several Lots and may submit joint offers.
EMA is pleased to announce a “Veterinary Big Data Stakeholder Forum” to be held virtually on 1-2 June 2021.
Inspired by the implementation of the Veterinary Medicines Regulation (EU) 2019/6 and in line with the European Network of Medicines Agency (EMAN) Strategy to 2025, we would like to open a conversation on the opportunities that new digital technologies offer in the Veterinary medicines domain.
As part of the HMA-EMA joint Big Data Task Force activities, this event intends to engage all relevant stakeholders to share their experience and views on the current use of “Big Data” and future needs and opportunities.
It will bring together regulators, the pharmaceutical industry, farm management system providers, academia, consumers and practitioners, to:
- build awareness on the use of innovative digital technologies in the veterinary regulatory environment;
- share needs, ambitions and opportunities;
- inspire future activities shaping the development of the European Veterinary Big Data Strategy.`
For further information, please see the draft programme overview.
The event will be broadcast live and further details will follow shortly with regard to speakers nominations and program details.
We would appreciate if you could already inform your respective affiliated Members to save the date for this online event.
For any questions on the event, please contact directly Vet-bigdata@ema.europa.eu
The European Medicines Agency has published for public consultation one reflection paper and four guidelines on veterinary medicines under Regulation (EU) 2019/6.
The new Veterinary Medicines Regulation (Regulation (EU) 2019/6) will modernise the existing rules on the authorisation and use of veterinary medicines in the European Union (EU) when it becomes applicable on 28 January 2022. It contains new measures for increasing the availability and safety of veterinary medicines and enhances EU action against antimicrobial resistance.
- Reflection paper on classification of a product as intended for a limited market and eligibility for authorisation according to Article 23 (Applications for limited markets)
- Guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6
- Guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6
- Guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6
Comments should be provided using this template and sent to vet-guidelines@ema.europa.eu by 15 May 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 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 (number) monograph(s) towards a possible revision of the monograph(s) 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.
- Arnica montana L., flos
- Camellia sinensis (L.) Kuntze, non fermentatum folium
- Cichorium intybus L., radix
- Cucurbita pepo L., semen
- Curcuma xanthorrhiza Roxb. (C. xanthorrhiza D. Dietrich), rhizoma
Please find below two documents also published for public consultation:
- Public statement on Salvia miltiorrhiza Bunge, radix et rhizoma
- European Union herbal monograph on Orthosiphon aristatus (Blume) Miq. var. aristatus, folium
Deadline for comments: 30 April 2021.
Please send your comments to hmpc.secretariat@ema.europa.eu by using the standard template.
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 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.
In these exceptional circumstances, many research groups in Europe and around the world are performing observational studies related to the utilisation and effects of drugs in relation to the Covid-19 pandemic.
In order to support the sharing of information on performed or planned studies and increase the efficiency of research, ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) and EMA (European Medicines Agency) strongly encourage all researchers to register their pharmacoepidemiological studies related to the Covid-19 pandemic in the EU PAS Register available on the ENCePP website through the following link: http://www.encepp.eu/encepp/studiesDatabase.jsp
Researchers are also encouraged to upload and make public their study protocols/results with a description of the data collected or planned to be collected in order to facilitate and speed-up the design of observational studies by others.
When registering the studies, researchers should include the term “COVID-19” in their study title. This will facilitate the retrieval of studies related to the Covid-19 pandemic when typing this term in the field “Title of Study” of the database’s search function.
Note: The important added value of registering studies in the EU PAS Register of course also applies to observational research non-related to Covid-19.
To better support you, we will organize a webinar early 2021 for ENCEPP members where instructions on the registration procedure will be illustrated in detail.
The European Medicines Agency (EMA) is developing 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.
