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Strengthening regulatory sciences and supporting regulatory scientific advice

Proposals should; (i) establish, regularly update and disseminate a comprehensive inventory[[Already existing initiatives and infrastructures should be integrated efficiently and to the fullest extent]] of existing support activities for regulatory Scientific Advice and Protocol Assistance in Europe such as the Innovation Task Force (ITF[[The Innovation Task Force (ITF) is working on matters relating to emerging therapies and technologies. EMA and the EU national competent authorities (NCAs) strengthened their collaboration to support medicine innovation and early development of new medicines by establishing the EU innovation network.]]) briefing meetings; (ii) analyse the effectiveness of existing support activities and develop a common strategy for training programmes to strengthen regulatory sciences and improve support for successful outcomes from regulatory Scientific Advice and Protocol Assistance based on identified best practices; (iii) support and/or advice for the delivery of corresponding pilot training programmes in an efficient and collaborative manner, and (iv) assess the need for and possibly propose additional mechanisms sustainably supporting academic groups in regulatory Scientific Advice and Protocol Assistance procedures.

A crucial objective is to complement, coordinate and/or harmonise efforts among Member States and at European level in order to support the main target group: academic clinical scientists. The aim is to reach these researchers very early in the planning process for relevant grant applications. A further aim is to strengthen regulatory knowledge in general by reaching clinical scientists during professional training and qualifications.

The relevant stakeholders must be involved in the consortium that will implement this action, in particular all interested national competent authorities (NCAs) alongside academic and industry representatives and associations with relevant experience. NCAs should have clearly identified contact points. Proposals should consider the involvement of the European Medicines Agency (EMA[[European Medicines Agency:]]) the Heads of Medicines Agencies (HMA) network[[The Heads of Medicines Agencies is a network of the Heads of the National Competent Authorities whose organisations are responsible for the regulation of medicinal products for human and veterinary use in the European Economic Area]] and EUnetHTA[[EUnetHTA Joint Action 3 is a European network of national/regional HTA bodies under the EU Third Health Programme]] at European level, in order to ensure (i) the comprehensiveness and validity of analyses, (ii) the feasibility and effectiveness of implemented and implementable activities and (iii) the impact of the whole project.

The Commission considers that proposals requesting a contribution from the EU of between EUR 1.5 and 2 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

A large proportion of EC and nationally funded projects in biomedical clinical research is focusing either on the development of novel active substances or on the optimisation of pharmacological treatments, such as novel indications or new treatment/dosing schemes for already registered pharmaceutical products.

For such innovations to achieve full impact, it is necessary to file for new marketing authorisations or request significant changes of the regulatory labelling of existing marketing authorisations to bring improvements from academic research into clinical practice. However, in a majority of cases, the clinical research conducted by researchers in academia does not fulfil regulatory requirements and thus, innovations do not reach the patients in a timely and efficient manner. Researchers often do not allocate enough time and resources and also lack specific relevant know-how to develop strategies enabling successful regulatory Scientific Advice procedures. This is partly because regulatory sciences are not well addressed in medical teaching and training programmes.

  • Improved knowledge of Regulatory Sciences among academic clinical researchers.
  • Improved success in regulatory Scientific Advice and Protocol Assistance procedures.
  • Improved direct regulatory impact of results from academic clinical research to ensure benefits for patients and healthcare systems.