Since 2011, innovation offices in national competent authorities (NCAs) have been working informally with the EMA's Innovation Task Force (ITF) on matters relating to emerging therapies and technologies. In 2015, the EMA and the (NCAs) strengthened their collaboration to support medicine innovation and early development of new medicines in the European Union by establishing the formal EU-IN. In October 2016 the EU-IN was formally endorsed as a working group of the Heads of Medicines Agencies (HMA).
The set up of the EU-IN network is part of the EMA’s network strategy to 2020 and the HMA multiannual workplan and represents an important new instrument in the arena of existing regulatory support mechanisms in Europe.
The aim of the network is to make the regulatory support for medicines developers currently available at national and European levels more visible and attractive to innovators, in particular by:
- sharing experience and knowledge by discussing case-studies, with sponsor agreement;
- identifying challenges for emerging innovation and leading experts in innovative fields;
- using the contacts of the NCAs with local academic groups and other innovators including SMEs, research groups …;
- sharing best-practices between the different national innovation offices of the NCAs;
- identifying emerging trends and innovative medicines that may require new regulatory guidance and/or support by the European medicines regulatory network;
- contributing to consolidating an European expert view on topics relevant to innovative therapies and technologies;
- addressing specific topics at the request of HMA and EMA scientific committees
Since 2015 the FAMHP participates actively in the European Innovation Network established by the EMA, the HMA and the European NCAs to support medical innovation and early development of new medicines in the European Union.
The FAMHP’s National Innovation Office functions as a local hub or interface with the EU-IN for any issues or queries from local innovators which may need further support and guidance at the European level.
In addition, EMA or the EU-IN may refer innovators already active at the European level for specific issues or queries to the local National Innovation Office of a specific NCA when needed.