Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP) (EMA/CAT/499821/2019) Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells ( CHMP/GTWP/671639/2008)

Advanced therapy medicinal products (ATMPs) require evaluation by the European Medicines Agency’s Committee for Advanced Therapies prior to being placed on the European market, subject to a Marketing Authorisation granted by the European Commission.

Advanced therapy medicinal products (ATMPs): what are they? why are they so different from other medicines? Why is there a special legislation for ATMPs? The European regulatory framework. Products against immune diseases, ...

invasive procedures are required to administer the ATMP or for the collection/extraction of the cells/tissues, control groups receiving placebo only should not be subjected to a procedure if it presents more than minimal risk and minimal burden.

Regulation (EC) No 1394/2007 on ATMPs provides the definitions of 'tissue-engineering product' and combined 'ATMP'. Part IV of Annex I to Directive 2001/83/EC provides the definitions for 'gene-therapy medicinal product' and 'somatic cell-therapy medicinal product'.

TRL Levels and Milestones ATMP. Regulatory Clearance & Market Preperation: TRL 1 TRL 2 TRL 3 TRL 4 TRL 5 TRL 6 TRL 7 TRL 8 TRL 9: Basic Research Preclinical Research/Proof of Concept: 5.4.1 Stability tested: - “expiration date” of the ATMP 6.3.5 Investigators brochure 5.4.2 Genetic stability: - Karyotype analyzed

Jan 31, 2025 · There is a need for tools to aid academic developers to understand the complex ATMP regulatory space. Whilst Technology Readiness Level (TRL) tools exist, they are simplistic in nature & do...

Feb 1, 2021 · The ATMP Regulation amended the Medicines Directive 2001/83/EC and Regulation 726/2004 on the procedures for authorisation of medicines under the centralised procedure (CeP) and establishment of the European Medicines Agency (EMA).

“The manufacture of sterile products is subject to special requirements in order to minimize risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved.

While in the EU, an ATMP can be sub-classified into four major groups, i.e., GTMP, SCTMP, TEP, or cATMP, in the US the sub-classification groups are broader, covering two groups of products, i.e., gene therapy and cellular therapy products.