Innovation in medicines
This content applies to human and veterinary medicines.
One of the European Medicines Agency's 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 EU-Innovation Network is starting a pilot for simultaneous national scientific advice (SNSA) from national competent authorities (NCAs) on 1 February 2020 to further strengthen early regulatory support for innovation.
The pilot project aims to develop a best practice model and will facilitate:
- broader expertise;
- early and simultaneously across selected Member States;
- consolidated views and identification of divergent opinions of the participating NCAs
- early identification of critical scientific or regulatory issues that may require scientific advice from EMA's Scientific Advice Working Party;
- knowledge sharing within the EU regulatory network to enhance preparedness for scientific innovation;
- optimisation of human and financial resources.
The pilot will start assigning two NCAs to each request for national scientific advice. Pending a positive evaluation at the end of 2020, it may be extended to include more than two NCAs in each request.
- Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA)
- Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA) - tracked changes
Innovation offices in national regulatory agencies have been working informally with the EMA's Innovation Task Force (ITF) on matters relating to emerging therapies and technologies since 2011. In 2015, EMA and the EU national competent authorities (NCAs) strengthened their collaboration to support medicine innovation and early development of new medicines in the EU by establishing the EU innovation network.
EMA and the HMAs adopted the mandate of the EU-Innovation Network in October 2016:
The aim of the network is to make the regulatory support for medicines developers currently available at national and EU levels more visible and attractive 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;
- using the contacts of the NCAs with local academic groups and other innovators including SMEs, research groups, etc.;
- 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 emerging trends that may require regulatory guidance and support by the European medicines regulatory network;
- contributing to consolidating an EU expert view on topics relevant to innovative therapies and technologies;
- promoting Heads of Medicines Agencies (HMAs) collaboration in the Innovative Medicines Initiative (IMI) projects;
- addressing specific topics at the request of HMAs and EMA scientific committees.
The 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.
Some of the topics the ITF has recently discussed include nanomedicines, biomaterials, pharmacogenomics, synthetic biology, modelling and simulation, and m-health ('mobile health', the use of mobile devices to support healthcare).
As of 24 May 2019, the ITF offers an early engagement platform for research and development efforts towards therapeutic approaches for the treatment or prevention of bacterial and fungal infections to tackle Antimicrobial resistance. This allows early interaction on such developments and broad-ranging discussion of relevant topics, with a view to steer the later preparation for formal scientific advice.
Any new medicinal product for the treatment of a life-threatening or debilitating fungal or bacterial (including mycobacterial) infection would be considered for discussion in the ITF. Developers are encouraged to apply for a briefing meeting at any stage during the development.
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.
Update: Before applying for an ITF briefing meeting, applicants should complete the ITF briefing meeting request form 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.