Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

ATMP Regulation EC (No) 1394/2007 Overview

Defines ATMPs and extends 2001/83/EC

ATMPs to be classified as medicinal products – full provisions of MP framework to be applied

Post authorization follow up and risk management

Donation and procurement of cells (Directive 2004/23/EC)

Traceability

Provides SME incentives

Mandatory centralized marketing authorization

Establishes an expert committee (CAT) for MAA assessment and scientific advice

Amendment of Annex 1 to 2001/83/EC: specific data requirements for ATMPs (2009/120/EC)

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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What are ATMPs?

“engineered” tissues or cells presented for treating, preventing or diagnosing a disease through the action of its cells or tissues

recombinant nucleic acid administered to human beings for regulating, repairing, replacing, adding or deleting a genetic sequence

“engineered” tissues or cells presented for regeneration, repair or replacement of human tissues

Gene Therapy

Somatic Cell Therapy

Tissue Engineering

“Engineered” = Substantially Manipulated

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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