FDA vs EMA a Comparison of New Chemical Entity Approvals: The Role of Start-Ups

OBJECTIVES: The EMA and the FDA regulate drug approvals in the European Union and the United States, respectively. Although their collaboration, the approvals for new active substances often differ. This analysis aims to identify the variables influencing approvals of new chemical entities, with particular attention to company size and the role of start-ups.

METHODS: Annual publications from the EMA and FDA between 2020-2023 on new chemical entity approvals were analyzed. Variables included designations like Breakthrough Therapy, PRIME, orphan drugs, and the company holding the marketing authorization, distinguishing between large companies and start-ups.

RESULTS: Between 2020 and 2023, the FDA approved 196 new chemical entities, while the EMA approved 189. Differences included, 38 new chemical entities, for which 4 from start-ups, were approved in the European Union but not in the United States and 73 new chemical entities, for which 23 from start-ups, were approved in the U.S. but not in the European Union. In the United States, 161 approved molecules are owned by large companies, with around 50% being American. Following them are 18 companies from the UK, 15 from Switzerland, and 12 from Japan. Additionally, among the 35 start-ups that received approval, 85% are American-owned. In the European Union, U.S. companies have received 79 approvals, followed by 23 from the UK, 21 from Switzerland, 13 from France, 12 from Japan. Of the 21 start-ups that obtained approval, 50% are American-owned.

CONCLUSIONS: The analysis suggests that designations by the EMA and FDA do not significantly impact new active substances approvals between the agencies. However, large companies dominate approvals in both markets. U.S. start-ups face challenges accessing the European market, likely due to their smaller structure and the complexity of the European market, fragmented across different member states, especially from a regulatory perspective.