PROJECT
Combination products will play an increasingly important role in biomedical innovation. Therefore, there is a strong need for adaptive regulatory systems that will be able to ‘absorb’ these innovations and make sure that promising new products are assessed in a thorough and predictable manner. In 2024, Exon Consultancy undertook a project to create an overview of the use of terminology by different regulatory authorities, accompanying regulatory routes and classification strategies.
Exon Consultancy conducted an extensive analysis of the terminologies used by leading regulatory agencies (e.g. EMA, FDA) for combination products, identifying critical elements, commonalities, and areas of divergence. Our analysis revealed significant discrepancies that could hinder the efficient regulation of combination products. These findings have been compiled into a detailed report. The findings suggest the need for more harmonisation for establishing an efficient and science-based regulatory approach, and for more engagement between developers of combination products and regulators to identify critical challenges for developing and regulating combination products.
More information about the project can be found here.
Client:
IFPMA
Date of completion:
2023
Project partners
