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.
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.
We would like to inform you of the third EMA public stakeholder meeting on the approval, safety monitoring and impact of COVID-19 vaccines in the EU to be held virtually on 26 March 2021 from 13:00 to 15:15 CET.
EMA is organising this open event to provide an update on:
- COVID-19 vaccines approved in the EU and those currently under review;
- post-authorisation activities, including emerging safety data since EU authorisation of the first COVID-19 vaccines, and ongoing work to address new variants;
- the expected impact of COVID-19 vaccination on our society;
- transparency and the publication of clinical data for COVID-19 vaccines.
The agenda and all information related to the event are available on the EMA website event page. The meeting will be broadcast live and a recording will be available after the meeting.
We hope that you and your members will be able to follow this important event and would like to encourage you to disseminate the information within your network.
No registration is required to watch the broadcast and those following the broadcast will be able to submit their comments via the COVID19-public-event@ema.europa.eu inbox during the meeting. Kindly note that by sending an email, you consent to the processing of any personal data in your email, read the related privacy statement here. EMA may publish your comments, in an anonymous format, on EMA’s website. Should you wish to opt-out from this, please state this in your email. While it may not be possible to address all comments received during the meeting, EMA will still consider them in the relevant regulatory decision-making processes.
We invite those of you interested to join the virtual meeting room in WebEx to complete and submit this form no later than 15 March 2021 (Note: we recommend using Google Chrome/Safari browser). Participating in the virtual room gives the opportunity to ask questions and/or write comments in the WebEx chat (time permitting). EMA will look at all requests to join and will endeavor, in view of the available time and capacity, to select a diverse group of stakeholders to join the virtual meeting.
Please contact COVID19-public-event@ema.europa.eu if you have any questions.
On behalf of the HMA-EMA Big Data Steering Group we are pleased to inform you of the upcoming “Technical workshop on real-world metadata for regulatory purposes” on Monday, 12 April 2021.
Data characterization and discoverability are goals for the scientific community and for medicines regulation. The HMA-EMA joint Big Data Task Force recommended “to promote data discoverability through the identification of metadata” as part of its Recommendation III, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to review and gather stakeholders’ feedback on a:
- preliminary list of metadata required for characterising real-world data sources, and their definitions;
- proposed process to collect and maintain metadata from real-world data sources;
- proof-of-concept catalogue of data sources and metadata currently being developed.
The above items are being developed by the MINERVA Consortium (Metadata for data discoverability and study replicability in observational studies) as part of the EMA-funded project Strengthening Use of Real-World Data in Medicines Development.
The workshop will be held as a virtual meeting. We anticipate space for a broad representation of stakeholders, and attendance will be organised through EU associations and by direct invitation.
To enable wide engagement, we plan to broadcast the workshop on the Internet.
An outline of the agenda and details on the registration process will be available shortly.
More information on this project can be found on EU Big Data webpage.
Should you have any questions on the upcoming workshop, please contact metadata@ema.europa.eu.
We would like to share with you our latest publications on COVID-19 vaccines, which have been compiled into one message to avoid email overload.
- AstraZeneca European Public Assessment Report (EPAR)
- EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
- EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
- Clarification on Sputnik V vaccine in the EU approval process
- EMA preparing guidance to tackle COVID-19 variants
We would like to remind you to check EMA’s dedicated webpage on COVID-19 for the latest updates.
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.
The European Medicines Agency has published for public consultation the following veterinary concept papers for guideline on data requirements for vaccines:
- Concept paper on the provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines
- Concept paper for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against Avian Influenza (AI), Blue Tongue (BT) and Foot and Mouth Disease (FMD)
- Concept paper for the development of a guideline on data requirements for vaccine platform technology master files (PTMF)
- Concept paper for the development of a guideline on data requirements for vaccine antigen master files (VAMF)
Comments should be provided using this template (one form for each concept paper) and sent to vet-guidelines@ema.europa.eu by 31 March 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 European Medicines Agency has published for public consultation a draft implementation guide for the Union Product Database.
It contains guidance for marketing authorisation holders and national competent authorities on the submission of data on veterinary medicines to the Union Product Database using standardised data formats and terminologies throughout the EU.
The different chapters of the guide explain the timelines, requirements, process, technical specification, data elements and associated business rules for submitting these data.
The UPD will draw on the four SPOR data management services for the centralised management of master data in the EU. For more information, see Substance, product, organisation and referential (SPOR) master data.
EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database
- Chapter 1: Registration and data access requirements for the User Interface (UI) and Application Programming Interface (API)
- Chapter 2: Format for the electronic submission of veterinary medicinal product information
- Chapter 3: Process for the initial submission and maintenance of veterinary medicinal products information
- Chapter 4: Process and format for the submission of legacy data on 8 veterinary medicinal products
- Chapter 5: Technical specifications
Stakeholders should send their comments to vetchange.programme@ema.europa.eu by 21 March 2021 using this form. They should fill in a separate form for commenting on each chapter.
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 European Medicines Agency has published for public consultation the revised “EudraVigilance Access Policy for Medicines for Veterinary Use”.
This Access Policy has been developed with the goal to facilitate the continuous monitoring of the safety of medicinal products for veterinary use, and the evaluation of the benefits and risks of medicines authorised in the EU, with the overall aim to promote and protect animal and public health.
Comments should be provided using this template and sent to Vet-Guidelines@ema.europa.eu by 21 March 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.
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.
