The EU Innovation Network (EU-IN) aims to enhance collaboration between European Medicines Agency (EMA) and national competent authorities (NCAs) on regulatory matters relating to emerging therapies and technologies.
This working group's mission is to support the development of innovative medicines and associated technologies.
It carries out its mission by:
EMA established this working group together with the Heads of Medicines Agencies (HMA) in 2015.
For more information on EMA's working parties and other groups, see:
The EU Innovation Network has a joint mandate from both the HMA and EMA:
Its joint workplan is also available:
A number of initiatives under the EU Innovation Network help developers of innovative medicines by:
For more information on EU-IN activities, see:
The EU Innovation Network is conducting horizon scanning to identify emerging trends and topics related to medicine development.
This initiative seeks to identify areas where regulatory action could be beneficial.
The resulting reports highlight key challenges and opportunities, and offer recommendations for action for the European medicines regulatory network and stakeholders.
Select the expandable panel below to access horizon scanning reports on topics such as new approach methodologies, nanotechnology and Alzheimer's:
The Borderline Classification subgroup is a subgroup of the EU Innovation Network. It offers an informal EU-wide forum.
The subgroup consists of representatives from national competent authorities with expertise in borderline classification.
Members discuss and share non-binding opinions on situations where it is unclear which pharmaceutical legal framework or regulation applies to a certain medicine.
Key activities of the subgroup include:
EMA and HMA launched a pilot project in 2021 to support the repurposing of medicines.
This project aimed to help non-profit organisations and academia gather or generate sufficient evidence on the use of an established medicine in a new indication. The scope was to have this new use formally authorised by a regulatory authority.
This is a way of making new treatment options available to patients.
EMA and HMA concluded this pilot in 2024.
For more information, see:
Applicants can use this mechanism to obtain national scientific advice from more than one national competent authority at the same time.
For queries on the pilot, including on participating NCAs, contact snsa@fagg-afmps.be.
For more information:
Select the expandable panel below to access documents related to the simultaneous national scientific advice:
The EU Innovation Network working group promotes the involvement and collaboration of competent authorities in relevant externally-funded projects.
To facilitate this, the working group has developed guidance for researchers and project teams outlining the circumstances under which competent authorities may engage in such projects related to medicinal products.
This guidance also specifies the information that should be submitted when seeking a competent authority’s involvement. EMA advises researchers and project teams to consider any existing position or guidance that individual competent authorities established on this matter.
For more information:
The Strengthening training of academia in regulatory science (STARS) was an EU-funded project that ran between 2019 to 2022.
It assessed the level of knowledge of academic drug researchers on regulatory sciences and the training offer in this area.
The STARS Common Strategy summarises the achievements of the project and opportunities to strengthen regulatory science and knowledge.
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.