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 regulatory advice to applicants on the eligibility to Agency procedures as a medicinal product, in conjunction with the Committee for Medicinal Products for Human Use (CHMP) and the European Commission as appropriate, for example:
- where there are uncertainties on whether the concerned therapeutic product would qualify as a medicinal products;
- for borderline products, having characteristics belonging to diverse legal frameworks, e.g. medicines and medical devices, food supplements;
- for (medicinal) substances incorporated in medical devices for which the medicinal and ancillary functions are borderline;
- establish a central information repository at the Agency allowing the review of 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.
Full details are available in this document:
The ITF holds briefing meetings with applicants covering regulatory, technical and scientific issues arising from the development of innovative medicines, new technologies and borderline products. These meetings are free of charge and are intended to facilitate the informal exchange of information and the provision of guidance early in the development process.
The ITF arranges these meetings within 60 days of receipt of a valid request from an applicant.
The discussions are led by experts from the Agency's network, working parties and committees, with the best available scientific expertise being represented.
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.
To apply for a briefing meeting, please complete the request form below and return it to email@example.com:
CHMP scientific recommendation on eligibility to the Agency’s scientific services
The ITF provides recommendations on whether innovative or borderline products are eligible for the Agency’s pre-authorisation scientific services.
These recommendations are provided free of charge within 60 days of receipt of a valid request from an applicant. They are provided in liaison with the CHMP and, where appropriate, the European Commission.
To request a CHMP scientific recommendation, please complete both documents below, and return them to firstname.lastname@example.org. Please take the submission dates into account.
- Pre-submission request form
- CHMP scientific recommendation on eligibility to the Agency’s scientific services request form
- List of submission dates
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- Standard operating procedure on the organisation of Innovation Task Force briefing meetings (medicines for human / veterinary use) (14/03/2013)
- Standard operating procedure for regulatory advice to applicants on the eligibility to European Medicines Agency procedures as medicinal products (according to Directive 2001/83/EC) (30/10/2006)