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 manner. 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 methodologies 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.
The EU Innovation Network (EU-IN) was established in 2015 to strengthen the collaboration between national competent authorities (NCAs) and the European Medicines Agency (EMA) on regulatory matters relating to emerging therapies and technologies. Its objective is to facilitate the development of innovative medicines and associated technologies by addressing gaps in early regulatory support, providing a platform to share good practices and strengthening engagement with innovators. It is comprised of representatives from innovation offices within NCAs and EMA’s Innovation Task Force (ITF).
The EU Innovation Network has a joint mandate from both the Heads of Medicines Agencies (HMA) and EMA (renewed 2020):
The aim of the network is to improve and make the regulatory support for medicines developers currently available at national and EU levels more visible and attractive to innovators, in particular by:
- sharing experience and knowledge by discussing case-studies, with sponsor agreement, to identify challenges for emerging innovation and leading experts in innovative fields, where appropriate;
- contributing to consolidating an EU expert view on topics relevant to the regulation of innovative therapies and technologies through collaboration with other relevant groups such as the Clinical Trials Facilitation Group (CTFG), Scientific Advice Working Party (SAWP), Health Technology Assessment (HTA) Bodies;
- implementing specific initiatives to raise awareness of and strengthen the supports available for innovators;
- supporting the EU network training centre (EU-NTC) by identifying training needs in the regulatory network;
- facilitating the establishment of innovation offices in other regulatory agencies through sharing best practice;
- identifying, through horizon scanning, emerging trends that may require regulatory guidance and support by the European medicines regulatory network;
- discussing and sharing opinions on borderline classification issues from a medicinal products perspective and collaborating with other groups on such issues as appropriate;
- promoting Heads of Medicines Agencies (HMAs) collaboration in the Innovative Medicines Initiative (IMI) projects and other EU funded schemes.
Strengthening Training of Academia in Regulatory Science (STARS)
Strengthening Training of Academia in Regulatory Science (STARS)
The EU-funded1 Coordination and Support Action (CSA) on the Strengthening Training of Academia in Regulatory Science (STARS) is a collaboration between 18 European National Competent Authorities (NCAs/EU IN members), four associate countries and the European Medicines Agency (EMA).
The project aims to reach out to medicine innovators in academia, to bridge the regulatory knowledge gap, and enhance the dialogue between academia and regulatory authorities.
Light green: STARS partner, dark green: associated STARS partner; Starokozhko et al., 2020
The STARS project has developed an online Comprehensive Inventory that assists European academic drug developers in finding various support services provided by NCAs, public actors and private entities. STARS has also initiated three pilot support activities, which aim to transfer best practices and to close gaps in regulatory knowledge and support that have been identified by performing systematic surveys of clinical research centres, research groups, funding bodies and NCAs.
The project pursues different activities, all of which aim to improve the regulatory knowledge and success of academic medical research.
The STARS consortium is developing curricula for training and education in regulatory knowledge, requirements and affairs. All of these activities are supported by communication and dissemination strategies, such as Stakeholder Workshops and a global conference, which will take place at the end of the project in June 2022.
Finally, the results and insights from the STARS activities are to be integrated into the STARS Common Strategy, which is the main roadmap to strengthening regulatory science and which aims to improve the support and optimise the outcomes of scientific advice and protocol assistance.
Further information and contact details are available on the STARS website.
1 This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825881
Simultaneous National Scientific Advice (SNSA)
The EU Innovation Network is running a pilot for simultaneous national scientific advice (SNSA) from national competent authorities (NCAs) to further strengthen early regulatory support for innovation.
The concept of SNSA is to offer national scientific advice from different NCAs at an early stage of development at the same time, optimising the quality and consistency of such advice. The NCAs will initially independently review the questions raised and then interact to ensure the maximum possible alignment of their positions prior to a joint advice meeting with the applicant.
The key objectives of this pilot project are to explore the needs/demands from the pharmaceutical sector (including large companies as well as local SMEs and academic research centres/hospitals) and to subsequently demonstrate the potential added value of the SNSA concept.
Due to the COVID-19 pandemic, the duration of this pilot, which started in February 2020, has been extended until the end of 2021 to allow additional experience to be gained. In addition to those NCAs that are already participating in the SNSA pilot, the extension phase envisages the participation of more NCAs on a voluntary case-by-case basis.
To optimise resources, the pilot project also aims to develop a best practice model, which will open up opportunities to provide:
- broader expertise;
- early and simultaneous interaction with NCAs across selected Member States;
- consolidated views and early identification of divergent opinions of the participating NCAs;
- early identification of critical scientific or regulatory issues that may require scientific advice from EMA's Scientific Advice Working Party (SAWP); EMA’s Emergency Task Force (ETF), etc.;
- knowledge sharing within the EU regulatory network to enhance preparedness for scientific innovation;
Details of the application process and the SNSA pilot procedure are available in a guidance document and any queries in relation to the process and to the selection of Member States should be addressed to SNSA@pei.de or alternatively to the NCA contact points listed in the guidance.
As part of its mandate, the EU Innovation Network is conducting horizon scanning for the identification of emerging trends. This aims to identify areas where action is needed to be taken by the European Medicines Regulatory Network in collaboration with other stakeholders.
Members and Representatives
- The EU-IN is composed of representatives of AT, BE, CZ, DE-PEI, DE-BfArm, DK, EE, ES, IS, FI, FR, HR, HU, IE, IT, MT, NL, NO, PL, PT, SE, SK and EMA.
New members may join.
- Chair: Laurence O´Dwyer, HPRA, IE
- Co-chair: Jordi Llinares García, EMA
- EMA provides the secretariat for the EU-IN.