Landscape analysis of synthetic polypeptides approved in the EU

Advances in synthetic drug development have added a new complexity to the regulatory landscape, which has become more noticeable with the recent approval of synthetic peptides referencing biological originators. In view of the different regulatory frameworks that are in place for biological and synthetically produced medicines, specific considerations should be given to regulating these products throughout the EU. In 2024, Exon Consultancy conducted a EU landscape analysis of the different regulatory approaches applied to synthetic peptides.

Our findings revealed inconsistencies and challenges within the current regulatory framework, affecting both clinical practice and pharmacovigilance. The project has resulted in a peer-reviewed publication which calls for more transparency as well as global alignment about regulatory procedures for chemically synthesised products.

More information about the project can be found here.

Client:
Novo Nordisk

Date of completion:
2024