Introduction and Overview
One of the HMA strategic goals is to foster research and the uptake of innovative methods in the development of medicines. This helps to make safe and effective innovative medicines available to patients in a timely maner. The priority Innovation is listed in the Multi-Annual Work Plan of the HMA in which the EU IN plays a vital role.
In order to ensure access to new medicines for patients it is essential for Europe to have a regulatory environment that understands and facilitates innovation. The Agency and the European medicines regulatory network support the development of innovative methologies by fostering greater collaboration across the regulatory network and especially the National Competent Authorities with academia.
Innovation offices in national regulatory agencies have been working informally with the EMA's Innovation Task Force (ITF) on matters relating to emerging therapies and technologies since 2011. In 2015, the EMA and the national competent authorities (NCAs) of the EU strengthened their collaboration to support medicine innovation and early development of new medicines in the EU by establishing the EU innovation network.
The mandate of the EU-Innovation Network is to:
- Develop an annual work plan to be agreed upon by the EMA and the HMAs
- Provide the EMA and the HMA with an annual update of the activities undertaken
- Share experience and knowledge; discuss case-studies, with the agreement of the sponsors, to identify challenging issues for emerging innovation and, as appropriate, identify leading experts in innovative fields
- Support the EU-NTC in identifying areas where training may be required to ensure the appropriate capability in the network
- Discuss best practices so that the EU network builds on success and encourages the establishment of innovation contacts points/offices in more regulatory agencies
- Provide for horizon scanning for HMA and EMA for the identification of emerging trends that may require actions by the European Medicines Regulatory Network
- Contribute to the consolidation of EU expert views on emerging and challenging topics relevant to innovative therapies and technologies, flagging issues that need regulatory guidance and support
- Promote the involvement and collaboration of HMA on the Innovative Medicines Initiative (IMI) projects
- Address specific topics at request of HMAs and EMA Scientific Committees.
Members and Representatives
- The EU-IN is composed of representatives of AT, BE, CZ, DE-PEI, DE-BfArm, DK, EE, ES, FI, FR, HR, HU, IE, IT, Lux, MT, NL, NO, PL, PT, SE, UK and EMA.
New members may join.
- Chair:Esa Heinonen, Fimea, FI
- Co-chair: Marisa Papaluca-Amati, EMA
- EMA provides the secretariat for the EU-IN.
- Guidance for applicants on a pilot for SNSA | pdf