Module 9 2024

03/09/2024

EU Marketing Authorisation: A Centralised Procedure

The Organisation for Professionals in Regulatory Affairs

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US Legal Framework

21CFR Chapter 9 Federal Food, Drug and cosmetics act

Two types of products:

● Gene (recombinant nucleic acid) and Cell therapies (more than minimally manipulated cells) are regulated under Section 351 of the Public Health Service Act (HS) ● Minimally manipulated product are HCT/P (human cell and tissue product) regulated solely under Section 361 of the PHS and 21 CFR Part 1271.10(a)

Review by CBER / Office for Tissues and Advanced Therapies (OTAT)

Environmental risk assessment: class waiver for cell therapies but not for gene therapies

The Organisation for Professionals in Regulatory Affairs

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