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)
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.
1This 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.
EU-IN is pleased to confirm that Heads of Medicines Agencies (HMA) has agreed on the extension of the pilot. The extension will consist of two phases.
During the first phase of the extension, which will run until Q3 2022, applications will be considered and processed based on the procedure described in the existing Guidance for applicants on a pilot for SNSA. Two National Competent Authorities (NCAs) will participate in each SNSA procedure with the option of inviting a third NCA as observer. Additional NCAs have agreed to consider participating in SNSA procedures on a voluntary opt-in basis for individual procedures.
In parallel, an optimised SNSA process building on the experience gained during the pilot to date is being developed to create a common SNSA “best-practices” procedure between the participating NCAs that could serve the future needs of the pharma sector and the Regulatory network. The second phase of the extension will start with the launch of this optimised SNSA process in Q3 2022 for a pilot period of two years. Details of the optimised process will be published in due course prior to the launch of this second phase.
Queries in relation to the process and to the selection of Member States should be addressed to SNSA or alternatively to the NCA contact points listed in the guidance. @ pei .de
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.
e-mail: EU-INSecretariat@ ema.europa .eu