This content applies to human and veterinary medicines.

EMA and its regulatory partners foster research and the uptake of innovative products, methods and technologies in the development of medicines, in line with:

Advice mechanisms

Innovation Task Force (ITF) briefing meetings provide developers a forum for early dialogue on innovative medicines with EMA.

They assist developers in deciding on next steps in their development programmes.

ITF briefing meetings:

  • cover regulatory, technical and scientific concerns arising from innovative medicines, technologies and methodologies;
  • should held at much earlier stage of the development than the scientific advice;
  • enable informal exchange of information and guidance in the development process, complementing existing formal EMA procedures;
  • are aimed at all types of developer, including academic researchers, micro, small and medium-sized enterprises (SMEs) and large pharmaceutical companies.

These meetings are free-of-charge and held virtually.

Areas of special support:

To apply for an ITF briefing meeting, complete the request form below and email it to: 

Innovation Task Force (ITF) briefing meeting request form

Innovation Task Force (ITF) briefing meeting - Briefing document template

Innovation Task Force (ITF) briefing meeting - Instructions on how to apply

Pharmaceutical companies with large medicinal product portfolios can apply to attend informal meetings with EMA to:

  • Identify any issues impacting the progress of product portfolios and assist successful development
  • Capture innovative and disruptive technologies
  • Anticipate the scientific and regulatory expertise needed to assess future applications

These meetings are free-of-charge and held virtually

EMA will open the application process for meetings in 2025 in the second half of 2024.

The application process for meetings in 2024 is closed.

Contact: 

EMA provides incentives and support for micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use, to promote innovation and the development of new medicines.

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EMA maintains a strong working relationship with European academics and researchers. This helps EMA prepare for future challenges and opportunities presented by advances in science and technology. 

EMA engages with academia, learned societies and research groups and offers support for academic developers.

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The European Medicines Agency offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.

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The European Medicines Agency can provide medicine developers advice on the most appropriate way to generate robust evidence on a medicine's benefits and risks.

EMA provides scientific advice to support the timely and sound development of high-quality, effective and safe medicines, for the benefit of patients. 

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The Quality Innovation Group (QIG) supports the translation of innovative approaches to the design, manufacture and quality control of medicines, to bring new therapies and help improve the supply of existing medicines to patients.

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Innovation initiatives

The EU Innovation Network (EU-IN) is a working group that helps the European medicines regulatory network facilitate the development of innovative medicines and associated technologies in the EU.

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EMA has identified around one hundred topics where research is needed to address knowledge gaps in regulatory science.

Research in these areas can support medicine development and evaluation, ultimately helping patients in the EU access innovative medicines that address their needs.

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The Accelerating Clinical Trials in the EU (ACT EU) initiative aims to develop the EU further as a competitive centre for innovative clinical research.

The European Commission, EMA and Heads of Medicines Agencies (HMA) run ACT EU together.

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The EU Health Programme, EU4Health, is a research funding programme offered by the EU.

It focuses on strengthening healthcare and promotes innovation.

Priorities areas include health promotion and disease prevention, digital transformation and healthcare staff.

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EMA and the European Commission provide support to medicine developers applying for funding under the European Union’s Horizon Europe programme in the area of health.

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European Partnerships such as the Innovative Health Initiative (IHI), ERA4Health, One Health Antimicrobial Resistance, Personalised Medicines Partnership and Rare Diseases Partnership fund research and innovation in health and interventions.

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Key innovation topics

EMA's scientific activities on artificial intelligence (AI) help medicine developers prepare marketing authorisation applications for human medicines.

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Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.

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EMA supports the implementation of the so-called 3Rs principles - replace, reduce and refine - for the ethical use of animals in medicine testing across the European Union (EU).

These principles encourage alternatives to the use of animals in the testing of medicines while safeguarding scientific quality and improving animal welfare where the use of animals cannot be avoided.

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The emerging and steady increase of microbes that are resistant to antimicrobial treatments has become a global public health concern that threatens the effective treatment of infectious diseases.

Combatting this threat, particularly resistance to antibiotics, is a high priority for EMA and the European medicines regulatory network.

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The European medicines regulatory network provides comprehensive advice on digital technologies to applicants, a rapidly evolving regulatory field.

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EMA's Novel Therapies and Technologies Working Party provides recommendations to the Committee for Veterinary Medicinal Products (CVMP) on all matters relating to veterinary novel therapies and technologies.

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EMA's Regulatory science strategy and the European medicines agencies network strategy set out recommendations in the field of genome editing technologies. 

More information: 

Genome editing EU-IN Horizon Scanning Report

 

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