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;
- nanotechnologies;
- pharmacogenomics;
- 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:
- itfsecretariat@ema.europa.eu for human medicines, or
- itfvet@ema.europa.eu 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:
The EU Innovation Network is a working group that supports the European medicines regulatory network in facilitating the development of innovative medicines and associated technologies in the European Union.
The group aims to strengthen the collaboration between national competent authorities and EMA on regulatory matters relating to innovative medicines and associated technologies.
EMA and the Heads of Medicines Agencies (HMA) set up this group in 2015.
For more information: