Introduction to cell therapy products, the first GMP appendix in China in the new regulatory Era

On November 28, 2019, the official website of the food and drug audit and inspection center of the State Drug Administration issued the GMP appendix - cell therapy products (Draft for comments), which is the first GMP appendix for cell therapy products in China, making up for the gaps in the regulatory and technical aspects of the production quality control of cell therapy products in China Seven related questions are interpreted Cell therapy usually refers to transplanting normal or bioengineered human cells into patients The new cells can replace the damaged cells, or have stronger immune killing function, so as to achieve the purpose of treating diseases According to the technical guidelines for research and evaluation of cell therapy products (Trial) issued by the State Food and Drug Administration on December 22, 2017, cell therapy products refer to: For the treatment of human diseases, the source, operation and clinical trial process meet the ethical requirements, and the living cell products from human body are developed and registered according to the relevant regulations of drug administration It is not applicable to blood components for blood transfusion, the regulated and untreated hematopoietic stem cell transplantation, reproductive related cells, and tissue and organ products composed of cells The cell therapy products mentioned in GMP appendix cell therapy products refer to: Human derived living cell products include those produced by cell lines, as well as immune cells, stem cells and tissue cells derived from autogenous or allogeneic sources It does not include blood components for blood transfusion, hematopoietic stem cell transplantation, reproductive related cells, and tissue and organ products composed of cells Cell therapy has shown higher and higher application value in the treatment of cancer, blood disease, cardiovascular disease, diabetes, Alzheimer's disease and other aspects Cell therapy products are also increasingly concerned by domestic and foreign pharmaceutical enterprises and national government departments However, the material composition and action mechanism of cell therapy products are different from small molecule drugs (chemical drugs) and large molecule biological drugs (biological products), so traditional production and quality control methods may not be fully applicable to cell therapy products, so relevant policies and regulations need to be formulated according to the characteristics of cell therapy products In 2009, the Ministry of health of the people's Republic of China for the first time included part of immunocytotherapy into the third type of medical technology for access management In more than ten years, it has experienced the development process from scratch, from lack to continuous improvement See the table below for details 3、 What are the special requirements for personnel in the production of cell therapy products? 4、 What are the special requirements for plant facilities and equipment in the production of cell therapy products? 5、 What are the special requirements of material management in the production of cell therapy products? 6、 What are the special requirements of production management in the production process of cell therapy products? 7、 What are the special requirements of environmental management in the production of cell therapy products? Reference