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
- 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:
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.
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, renewed in 2020. For more information:
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:
Simultaneous national scientific advice
The EU Innovation Network has been running a pilot for simultaneous national scientific advice (SNSA) from NCAs since February 2020.
This aims to enable innovators to access scientific advice simultaneously in different EU Member States.
EMA and the Heads of Medicines Agencies (HMA) extended the pilot in 2021 and 2022.
The current extension consists of the two phases described below.
For queries on the pilot, including on participating NCAs, contact SNSA@pei.de or the NCA contact points listed in the guidance below.
For more information:
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.