Exploratory assessment of the current EU regulatory framework for development of advanced therapies

Pawanbir Singh
Laure Brévignon-Dodin
Satya P Dash

DOI:https://doi.org/10.5912/jcb351

Abstract:

The Advanced Therapy Medicinal Products (ATMP) Regulation provides a necessary regulatory framework for the commercialisation and use of regenerative medicine-based therapeutic products in the EU. However, concerns have been raised about the appropriateness of the regulatory strategy it has adopted to address different, complex and evolving categories of medicinal products. This article explores some of the potential shortfalls of the ATMP Regulation with regard to facilitating the research and development of advanced therapies in the present and in the future. It concludes that while providing a much needed harmonised regulatory framework for the companies operating in the sector, the new regulation has yet to demonstrate its capacity to keep up with radical technology changes.

Keywords:ATMP ,regulation ,cell therapy medicinal products ,gene therapy medicinal products ,tissue-engineered products ,demarcation issues ,en ,