Training and Regulatory Support Services from the European Medicines Agency
Most EIC projects proposing new technologies and therapies for human health lack a significant understanding of potential regulatory barriers and how to navigate complex regulatory frameworks. In some cases, these obstacles are hindering the emergence of new technologies or therapeutic approaches before any market challenge. The European Medicines Agency (EMA) offers valuable services to researchers and SMEs to identify and address regulatory issues from the early phases in the laboratory all the way to the patient (watch here from min 32 to 1 h 09 min the general presentation on the EMA services and access here the slides). These services are instrumental to decrease the risk of failure of EIC Health projects and increase the likelihood that their innovations will reach the patient or the medical market.
The EMA support services are:
- Innovation Task Force Briefing Meeting - informal regulatory advice especially for early stage development of medical technologies and therapeutics. Free for all applicants types including academia and SMEs
- SMEs Briefing Meeting - informal meeting on regulatory strategy of a medicinal product development at any stage. For SMEs only and free.
- Advanced therapy medicinal products (ATMP) Classification - informal on whether a medicine being developed meets the ATMP scientific criteria (early stage). Free to SMEs and Academia.
- Advanced therapy medicinal products (ATMP) Certification – formal advice to identify any potential issues early on, so that these can be addressed prior to the submission of a marketing-authorisation application. Fees incentives for SMEs and Academia. SME specific procedure and fee incentive applying.
- Scientific Advice/protocol assistance – formal clarification on the scientific requirements for Marketing Authorization and, if applicable, formal qualification of innovative methodologies for medicine development. Fees incentives for SMEs and Academia depending on the case.
- Priority Medicines Scheme (PRIME) - to expedite the approval of medicine for unmet medical needs. Early entry point and free for SMEs and Academia.
- Recording of the EIC – EMA InfoDay: Regulatory support for the development of innovative medicines and technologies offered on 31/01/2023/ can be found here. The slides of the presentations can be found here.
- A general overview on these services is available here prepared by the EIC-EMA working group for EIC beneficiaries.
- Please check the events EMA website and the events EIC Community website for future offerings of training on EMA services.
- For SMEs only: please check the SMEs Newsletter for training and regulatory news.
Contact us or EMA
Contact point for the EMA-EIC collaboration: Barbara Gerratana firstname.lastname@example.org
EMA contact entry points if you are still uncertain to which service you should apply, and when or how to apply: