EMA Consults on Genetically Modified Cell Products Guideline

Regulatory NewsRegulatory News
| 31 July 2018 | By Michael Mezher 

The European Medicines Agency (EMA) on Tuesday released a draft revision of its 2012 guideline covering quality, non-clinical and clinical aspects of medicines containing genetically modified cells for public consultation.
The draft revision was adopted for consultation by both EMA's Committee for Advanced Therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP) earlier this year and will be open for comments through July 2019.
EMA says the guideline is being updated to account for recent developments in the field of genetically modified cell therapies.
"The quality section has been updated to take account of the evolution of science and regulatory experience with an emphasis on starting materials (also considering implications for genome editing reagents/tools), comparability and validation," EMA says.
The section on nonclinical development has also been updated to reflect the agency's current thinking on requirements for CAR-T cell and T-cell receptor (TCR) products, induced pluripotent stem cell derived cell-based products and cell-based products derived from genome editing.
Additionally, the section covering clinical development has been revised to incorporate experience gained by the agency from providing scientific advice and reviewing marketing authorization applications (MAAs) for genetically modified cell products since the original guideline was adopted.


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