China defines cell therapy as drug with new GMP
Minhua Chu ·01/24/2022
Regulatory


Cell therapy is an innovative therapy that has emerged in recent years, but it has been subject to some awkward regulations in China.  According to the National Health Commission (NHC), hospitals can legally use it as a medical technology in hospitals through admission approval. On the other hand, it can also be marketed as a drug, with approval from the NMPA. The vast majority of cell therapy developers have chosen the former approach, which is a relatively simpler process.


However, this situation is changing. Last year, the  autologous CAR-T therapies from Fosun Kite and JW Therapeutics became the first and second cell therapies, respectively, to be launched as drugs in China.


In February and December, the CDE issued two technical guidelines to regulate the development of immune cell therapy products and genetically modified cell therapy products, respectively. As the administrative authority for hospitals, the NHC publicly stated that stem cells, immune cells and other cell products have obvious drug properties [and the NHC] will actively support and guide firms to develop products as drugs.


These measures show that China's regulation of cell therapy is transitioning its classification from medical technology to drug. The release of Good Manufacturing Practices (GMP) for Pharmaceutical Products - Cell Therapy Products Appendix (draft for comments) at the beginning of the new year is also an important step in regulating these cell therapies.


The regulations will be available for comments until February 7, 2022. This is the second draft for comments on the regulation, following the first release in November 2019. Compared to the previous version, the updated regulation has major changes.


Clearly defined cell therapy products


The regulations provide a clear definition of cell therapy products: “Cell therapy products are live cell products of human origin, including cells with or without genetic modification, such as autologous or allogeneic immune cells, stem cells, tissue cells, or cell lines and other products, excluding blood components for transfusion, transplanted hematopoietic stem cells, reproduction-related cells, and tissue and organ products composed of cells.”


The regulations also noted that the manufacture, inspection and release of genetically modified vectors or other biological materials (including: viruses, plasmids, RNA, antigenic peptides, antigenic proteins, protein-RNA complexes, etc.) directly used in the manufacturing of cell products should comply with the current version GMP and its relevant appendices.


Detailed regulation for the special characteristics of cell therapy products


The regulations point out that cell therapy products are different from the usual pharmaceutical products with special characteristics. Donor materials are from the human body and may contain infectious pathogens. The quality may vary. Moreover, the manufacturing batches are usually small, the impact of temperature on quality is more significant, and the products are susceptible to microbial contamination or cross-contamination.


In particular, autologous cell products or allogeneic products that require matching with patients for use may have serious life-threatening consequences if there is a mismatch between donor materials or cells and the patients.


Therefore, the regulations require companies to take special control measures for the entire process of donor material collection and product manufacture. These include taking risk assessments and developing risk control strategies, management systems and records; monitoring the temperature of the products/environment; and avoiding cross-contamination. They also call for proper labeling practices and ensuring that products are fully traceable. This would entail a validated computerized system in which each donor is given a unique number or code.


The regulations specify in detail the requirements for personnel, plant, facilities and equipment, donor screening, materials, manufacture, and quality management. They also mention that companies should sign quality agreements with accredited and qualified hospitals; regularly review and evaluate the collection of donor materials; and use the products in hospitals. 

Keywords: cell therapy GMP manufacturing practices
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