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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.
The European Medicines Agency has published information on the development and evaluation of vaccines for COVID-19:
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment of the vaccine known as Moderna Covid-19 vaccine (also referred to as mRNA1273) will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data from laboratory studies and also started assessing data on immunogenicity (how well the vaccine triggers a response against the virus) and safety from an early study.
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available.
EMA’s human medicines committee (CHMP) has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus. The company is currently conducting trials in people to assess safety and immunogenicity (how well the vaccine triggers a response against the virus), and effectiveness. EMA will evaluate data from these and other clinical trials as they become available.
You can also consult our EMA’s dedicated webpage on COVID-19 for the latest updates.
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.
We are pleased to announce that the registration for the first “EU Big Data Stakeholder Forum” is now open. Please find below the agenda of the event which will take place on 15 December 2020.
The objectives of this meeting are to:
- Inform on implementation of the HMA-EMA Big Data Task Force priority recommendations.
- Understand stakeholders’ perspectives.
- Discuss opportunities for stakeholder collaboration and priorities.
Agenda.pdf (275.0 KiB, 6 hits)
Agenda.pdf (275.0 KiB, 6 hits)
To ensure balanced stakeholders’ representation and considering the limited number of available places on our virtual platform, we kindly ask each association to nominate a maximum of 2 attendees to participate in this forum.
Please note that a live broadcast will also be available to listen to the presentations and discussions, no registration will be required for this option. A link to access the broadcast will be available via the event webpage on the day of the meeting.
To register, please complete the registration form and send it to EUBDStakeholderForum@ema.europa.eu by 26 November 2020.
Registration_form.xlsx (15.7 KiB, 10 hits)
Registration_form.xlsx (15.7 KiB, 10 hits)
Each registered participant will receive an email confirmation containing virtual meeting login details, reading materials and a request to participate in a short pre-meeting survey to help the preparation of the forum. The results of the survey will be presented at the forum.
Once the registration process has been completed, we will be contacting stakeholder associations to identify speakers.
Should you have any questions regarding this meeting, please send an email to: EUBDStakeholderForum@ema.europa.eu.
EMA will organise a public meeting on 11 December 2020 to inform European citizens about the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.
The COVID-19 pandemic is an unprecedented global crisis, with devastating health, social and economic impact. Safe and effective vaccines for COVID-19 are urgently needed to respond to this crisis and reduce its effects.
Together with the European medicines regulatory network, EMA is supporting the development of COVID-19 vaccines and has taken steps to speed up the evaluation processes for these vaccines. The Agency and its partners are doing so while ensuring that the same high regulatory standards for quality, safety and efficacy are being applied to COVID-19 vaccines.
The public meeting will inform citizens about EMA’s role in the pandemic and of EU regulatory procedures. It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
Those interested in making an intervention during the public meeting should fill in this form no later than 27 November 2020. EMA will look at all requests and, in view of the available time, will select a group of people to speak at the meeting. EMA will publish the list of speakers who will make an intervention in advance of the event.
The public meeting will be broadcast live and will be open to all citizens. In addition to the selected list of speakers, during the meeting there will be a mailbox open via EMA’s website for the public to make comments.
The agenda and all information related to the event are available on the EMA website event page.
Please check EMA’s dedicated webpage on COVID-19 for the latest updates.
After nine years as the Executive Director of the European Medicines Agency, my tenure will come to an end this month. It has been a great honour and privilege to lead the Agency through some extraordinary - and unexpected - challenges and I am proud of what we have achieved together.
When I took office in 2011, it was immediately clear to me that collaboration with EMA’s stakeholders and partners deserved a privileged and dedicated approach, reflecting the importance of these relations for the strong functioning of our Agency and the European medicines regulatory network on whose expertise we depend.
Today I believe that EMA is not only a respected member of the international medicine regulators’ community, but that we have forged closer relations with national competent authorities, EU institutions and EU agencies, and patient organisations in the EU, involving them closely in our work.
I have not been alone on this journey and have been grateful for the support of EMA’s talented and resilient staff, as well as the broader community of colleagues in the network.
As I write, many countries across the globe are struggling with the COVID-19 pandemic. Over the next weeks and months, any developments in relation to the approval of COVID-19 treatments and vaccines in the EU will generate significant public interest and all eyes will be on EMA.
I am happy to hand over the baton at this critical time into the capable hands of Ms Emer Cooke whom I have had the pleasure of working with over the years. I know Emer to be a strong and committed leader with the right background and experience to lead EMA during this very challenging period and ensure that the Agency’s work on COVID-19-related activities continues uninterrupted.
I would like to convey my heartfelt gratitude to you for all that we have shared – the challenges as well as the successes - and hope that you will continue to support EMA in its commitment to public and animal health and the advancement of science, medicines and health for the benefit of citizens across the EU.
With best regards
Guido Rasi, Executive Director
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.
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 firstname.lastname@example.org
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 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 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.
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 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.