The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) created the EU Innovation Network in 2015 to strengthen the collaboration between national competent authorities (NCAs) and EMA on regulatory matters relating to emerging therapies and associated technologies.
The EU Innovation Network's aim is to improve regulatory support for medicine developers at national and European level in order to make investment in innovative medicines more appealing.
The EU Innovation Network has a joint mandate from HMA and EMA:
Its joint workplan is also available:
A number of initiatives under the EU Innovation Network help developers of innovative medicines by:
The EU Innovation Network works to identify emerging trends and topics in science and technology that have relevance to medical research and development. This is called horizon scanning.
It delivers topic-specific reports that explore challenges and opportunities in these areas from a regulatory perspective. The reports include recommendations for action aimed at the European medicines regulatory network and stakeholders.
These reports are available below:
The EU Innovation Network is responsible for discussing and sharing non-binding opinions on situations where it is unclear which pharmaceutical legal framework or regulation applies to a certain medicinal product.
EMA and HMA launched in 2021 a pilot project to support the repurposing of medicines.
The aim of this project was to help non-profit organisations and academia gather or generate sufficient evidence on the use of an established medicine in a new indication, with the view to have this new use formally authorised by a regulatory authority.
This is a way of making new treatment options available to patients.
For more information:
Applicants can use the SNSA when they wish to obtain national scientific advice from more than one NCA at the same time.
For queries on the pilot, including on participating NCAs, contact SNSA@pei.de.
For more information:
Guidance is available for researchers and project teams on how to seek the support and participation of competent authorities as partners in externally funded research projects related to medicines, such as those available under Horizon Europe and the Innovative Health Initiative funding frameworks.
This guidance outlines the information that project teams should provide to a competent authority when requesting its involvement in such a research project.
For more information:
STARS was an EU-funded project that run between 2019 to 2022. It assessed the level of knowledge of academic drug researchers on regulatory sciences and the training offer in this area.
For more information:
The EU Innovation Network is represented by members of innovation offices within NCAs and EMA’s Innovation Task Force.
The contact details of the national innovation offices are also available below:
Contact of the EU Innovation Network:
Below are the current members of the EU Innovation Network in alphabetical order of surname. The members' declarations of interests are available in the European experts list.