Innovation in medicines
This content applies to human and veterinary medicines.
One of the European Medicines Agency's (EMA) strategic goals is to foster research and the uptake of innovative methods in the development of medicines. This helps to make safe and effective innovative medicines available to patients in a timely manner.
In order to ensure access to new medicines for patients it is essential for Europe to have a regulatory environment that understands and facilitates innovation. The Agency and the European medicines regulatory network support the development of innovative methodologies by fostering greater collaboration across the regulatory network and with academia.
The Innovation Task Force (ITF) is a multidisciplinary group that includes scientific, regulatory and legal competences. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development.
The objectives of the ITF are to:
- establish a discussion platform for early dialogue with applicants, in particular micro, small and medium-sized enterprises (SMEs), academics and researchers, to proactively identify scientific, legal and regulatory issues of emerging therapies and technologies;
- address the impact of emerging therapies and technologies on current scientific, legal and regulatory requirements with the Agency's committees and their working parties;
- identify the need for specialised expertise at an early stage;
- provide advice on the eligibility to Agency procedures relating to research and development, in conjunction with the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the European Commission and national competent authorities (NCAs) as appropriate, for example:
- where there are uncertainties on whether the concerned therapy contains a medicinal substance;
- for borderline products (products for which there is uncertainty over whether they fit the definition of a medicinal product or not);
- for (medicinal) substances incorporated in medical devices for which the medicinal and ancillary functions are borderline;
- review the regulatory and scientific implications of emerging therapies and technologies, in conjunction with the Agency's committees and their working parties;
- increase awareness and learning in emerging therapies and technologies at the Agency.
For more information on how the ITF operates see the mandate below:
ITF briefing meetings provide a forum for early dialogue on medicines innovation. They cover regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products – but ITF briefing meetings are intended to be much earlier than when one would normally seek scientific advice.
ITF briefing meetings facilitate informal exchange of information and guidance in the development process, complementing and reinforcing existing formal procedures such as advanced-therapy-medicinal-product (ATMP) classification and certification, designation of orphan medicinal products and scientific advice.
The objectives are two-fold: firstly, for EMA to help clarify questions regarding the road to market of innovative medicines and secondly, to help ensure EMA awareness and preparedness for assessment of the most recent developments in innovative medicine.
The informal scientific brainstorming-discussions are led by experts from the Agency network, working parties and committees.
ITF also covers the regulatory acceptance of so-called new approach methodologies (NAM) to replace the use of animals in the testing of medicines, in line with the 3Rs principles (replacement, reduction, refinement). NAMs include, for example, in silico modelling and novel in vitro assays.
This aims to encourage the development of NAMs, and to enable their integration in the development and evaluation of medicines.
For more information:
- Ethical use of animals in medicine testing
- Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline
- Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken
The ITF particularly invites developers to ask questions and apply for a briefing meeting to discuss NAM and treatments intended to tackle antimicrobial resistance (AMR).
Some topics the ITF has discussed include:
- complex clinical trial methodologies;
- digital technologies (including artificial intelligence and machine learning);
- innovative manufacturing methods;
- smart materials and synthetic biology;
- innovative methods for medicines in pregnancy and breastfeeding;
- combination products and trials;
- platform technologies for new medicines.
The Innovation Taskforce (ITF) encourages developers of innovative medicines, technologies and methods to apply for a briefing meeting.
Applicants should complete the ITF meeting request form below and send it to:
- email@example.com for human medicines, or
- firstname.lastname@example.org for veterinary medicines.
EMA will review the form and advise applicants on how to proceed.
Successful applicants need to prepare the submission via the IRIS platform.
The meetings are free of charge.
For more details on the process and relevant documents please see:
EMA and the Heads of Medicines Agencies (HMA) set up the EU Innovation Network in 2015 to strengthen collaboration between national competent authorities (NCAs) and EMA on regulatory matters relating to emerging therapies and technologies.
Its objective is to facilitate the development of innovative medicines and associated technologies by addressing gaps in early regulatory support, providing a platform to share best practices and strengthen engagement between regulators and innovators. It comprises representatives from NCA innovation offices and EMA’s Innovation Task Force (ITF).
The EU Innovation Network has a joint mandate from the HMA and EMA:
Update: A joint workplan is also available:
The network aims to improve regulatory support for medicine developers at national and EU levels and make this more appealing to innovators, in particular by:
- sharing experience and knowledge by discussing case studies, with sponsor agreement, to identify challenges for emerging innovation and leading experts in innovative fields, where appropriate;
- contributing to consolidating an EU expert view on topics relevant to the regulation of innovative therapies and technologies by working with relevant groups such as the Clinical Trials Facilitation and Coordination Group (CTFG), Scientific Advice Working Party, and Health technology assessment bodies;
- implementing initiatives to raise awareness of and strengthen the support available for innovators;
- supporting the EU Network Training Centre (EU-NTC) by identifying training needs in the regulatory network;
- facilitating the establishment of innovation offices in other regulatory agencies through sharing best practice;
- identifying, through horizon scanning, emerging trends that may require regulatory guidance and support by the European medicines regulatory network;
- discussing and sharing opinions on borderline classification issues from a medicinal products perspective and working with other groups on such issues;
- promoting HMA collaboration in the Innovative Medicines Initiative (IMI) projects and other EU-funded schemes.
In order to further the objectives of the EU Innovation Network, the following initiatives have been launched.
Training for academia
The EU-funded Coordination and Support Action (CSA) on the Strengthening Training of Academia in Regulatory Science (STARS) aims to reach out to medicine innovators in academia, bridge the regulatory knowledge gap and enhance dialogue between academia and regulatory authorities.
For more information:
Involvement of competent authorities in externally funded projects (new)
Guidance is available for researchers and project teams on how to seek the support and participation of competent authorities as partners in externally funded research projects related to medicines, such as those available under the Innovative Health Initiative and Horizon Europe funding frameworks.
This guidance outlines the information that project teams should provide to a competent authority when requesting its involvement in such a research project.
Project teams should also consider any existing guidance that an individual competent authority may have in place regarding such requests.
EMA and HMA made this guidance available in February 2023.
This is in line with the EU Innovation Network's role in promoting the involvement and collaboration of competent authorities in relevant externally funded projects.
Simultaneous national scientific advice
In November 2022, the EU Innovation Network launched the second phase of the simultaneous national scientific advice (SNSA) pilot.
SNSA is intended for situations where an applicant wishes to obtain scientific advice from more than one national competent authority (NCA) at the same time. This is meant to enhance the quality and consistency of such advice.
Following endorsement by the Heads of Medicine Agencies (HMA), the second phase of the SNSA pilot will run for a two-year period until the end of 2024.
It incorporates an optimised procedure to maximise the benefits for both applicants and competent authorities.
For queries on the pilot, including on participating NCAs, contact SNSA@pei.de.
For more information, see:
Application form to request a simultaneous national scientific advice (SNSA) (DOCX/96.1 KB)
First published: 22/11/2022
Guidance for applicants on simultaneous national scientific advice (SNSA) briefing book format and content (PDF/174.55 KB)
First published: 22/11/2022
Guidance for applicants on simultaneous national scientific advice (SNSA) phase 2 pilot (from October 2022) – Optimised process (PDF/294.89 KB)
First published: 22/11/2022
List of NCA’s participating in the Simultaneous National Scientific Advice (SNSA) pilot phase 2 (PDF/175.38 KB)
First published: 22/11/2022
Last updated: 07/12/2022
Launch of phase 2 of the Simultaneous National Scientific Advice pilot (PDF/205.11 KB)
First published: 28/11/2022
Identifying emerging trends
The EU Innovation Network conducts horizon scanning to identify emerging trends and topics in science and technology with relevance to medical research and development. It delivers topic-specific reports exploring challenges and opportunities in these areas from a regulatory perspective, with recommendations for action by the European medicines regulatory network and stakeholders.
These reports are available below.