TOPRA Symposium 2023: Support and assistance for SMEs

Part four: Authority interactions and regulatory support for SMEs, academia, and start-ups

The European Medicines Agency (EMA)’s Leonor Enes provided an overview of how the regulatory body supports Small and medium-sized enterprises (SMEs) and academic institutions.

The EMA SME office aids SMEs in line with the EU regulation (EC) No. 2049/2005 of 15^th December 2005.

Led by a multidisciplinary team, SME briefings serve as a conduit for early dialogue with SMEs to discuss regulatory strategy and product development, obtain scientific advice, and facilitate access to SME incentives.

They are also used to discuss PRIME eligibility, orphan drug designation, paediatric requirements, and pre-/post-licensing evidence generation.

Furthermore, the EMA has published a SME user guide which provides an overview of all legislation.

The framework for collaboration with academic institutions was implemented in 2017 and promotes regulatory support for translating academic research into novel methodologies and medicines.

Miguel Forte, President Elect of the International Society for Cell and Gene Therapy, followed with the industry perspective, stressing the need for the applicants to seek regulatory scientific advice to improve product development.

Early regulatory interaction and collaboration are critical in understanding regulatory expectations.

Conclusion:

The TOPRA Symposium provided an excellent oversight of the EU pharmaceutical legislation framework, and how the competent authorities and industry are adapting to this.

Both the EMA and U.S. Food and Drug Administration (FDA) recognise that real-world evidence (RWE) and patient engagement are key factors in the development of, and acceleration of access to, innovative medicines.

These regulatory bodies are working on their own independent frameworks, as well as working collaboratively to advance global healthcare.

Rachael O’Kane is a Manager, Regulatory Affairs at G&L.