This content applies to human and veterinary medicines.
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 European Medicines Agency and to provide a forum for early dialogue with applicants.
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) 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.
Recent areas of ITF engagement have included nanomedicines, pharmacogenomics, synthetic biology, biomaterials, modelling and simulation, and m-health ('mobile health', the use of mobile devices to support healthcare).
Further details are available in the Mandate of the European Medicines Agency Innovation Task Force. The Agency plans to update this mandate to reflect the inclusion of a new initiative, the 'EU-ITF network', in the near future.
Briefing meetings organised under the remit of the Innovation Task Force (ITF) provide a forum for early dialogue regarding medicines innovation. Their scope covers 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 aim to facilitate informal exchange of information and guidance in the development process, complementing and reinforcing existing formal procedures. The objectives are twofold: firstly, for the 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 scientific informal brainstorming discussions are led by experts from the Agency network, working parties and committees. The meetings are free of charge.
Briefing meetings are intended to complement and reinforce existing formal regulatory procedures, such as advanced-therapy-medicinal-product (ATMP) classification and certification, designation of orphan medicinal products and scientific advice.
For human medicines based on cells, genes or tissues, a scientific recommendation on ATMP classification can also be provided by the Committee for Advanced Therapies (CAT).
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- Standard operating procedure on the organisation of Innovation Task Force briefing meetings (medicines for human / veterinary use) (14/03/2013)
- Work instructions for additional administrative actions for veterinary medicines arising during the preparation of Innovation Task Force briefing meetings in line with SOP/H/3044 (26/03/2014)