Cell and gene therapy (CGT) had developed rapidly since 2017 when two CAR-T cell therapy drugs were approved by FDA. However, quality research and quality control are more complicated due to the large heterogeneity in the cell source, type, and in vitro operation of cell and gene therapy products. FDA and EMA issued a series of guidelines to standardize the research and development of CGT products and improve their safety, effectiveness, and quality control ability.
FDA\EMA CGT Drug Regulation
|FDA||Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)|
|FDA||Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up|
|FDA||Long Term Follow-Up After Administration of Human Gene Therapy Products|
|FDA||Human Gene Therapy for Retinal Disorders|
|FDA||Human Gene Therapy for Rare Diseases|
|FDA||Human Gene Therapy for Hemophilia|
|FDA||Recommendations for Microbial Vectors used for Gene Therapy|
|FDA||Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products|
|FDA||Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products|
|FDA||Preclinical Assessment of Investigational Cellular and Gene Therapy Products|
|FDA||Potency Tests for Cellular and Gene Therapy Products|
|EMA||Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials|
|EMA||Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products|
This web search service is supported by Google Inc.