NMPA (formerly CFDA) Solicits Public Comments on “Good Manufacturing Practice (GMP) – Appendix for Cellular Therapy Drugs” (Draft for Comments)

Chapter 1 Scope

Article 1 [Scope] The cell therapy products described in this appendix refer to living cell products of human origin, including products produced by cell lines, as well as immune cells, stem cells and tissue cells derived from autologous or allogeneic sources.

Blood components for transfusion, hematopoietic stem cell transplantation that has been regulated, reproductive-related cells, and tissue and organ products composed of cells are not included.

Article 2 [Scope of Application] The provisions of this appendix apply to the entire process of cell therapy products from the transportation, receipt, production and inspection of donor materials to the release, storage and transportation of finished products.

For the collection of donor materials and the use of products, enterprises shall establish requirements for the collection of donor materials and the use of products and provide training.

Article 3 [General Requirements] The production and quality control of cell therapy products shall comply with the requirements of this appendix and relevant national regulations.

Chapter II Principles

Article 1 [Speciality] Cell therapy products have the following special characteristics, and special control should be implemented for their production process and inspection of intermediate products:

(I) [Cell source and individual differences] Donor materials used for cell therapy products have inherent variability, and their quality is affected by factors such as the source, type, nature, function, biological activity, and individual differences of donors, including pathogens that may carry infectious diseases;

(II) [Process characteristics] The production batch size is small, and autologous cell therapy products need to be divided into production batches according to individual donors. During the production process, it may be necessary to make necessary adjustments to the production process within the scope of registration approval based on the variability of donor materials;

(III) [Product speciality] Cell therapy products are usually sensitive to temperature. The product temperature and the time limit of the corresponding process steps should be monitored during the production process, and the production, inspection, release and use of the product should be completed within the specified time limit;

(IV) [Prevention of contamination and cross-contamination] In view of the variability of donor materials and the possibility of containing pathogens of infectious diseases, and the culturing process is prone to contamination, the entire production process of cell therapy products should pay special attention to preventing microbial contamination;

(V) [Traceability] If there is confusion in autologous cell therapy products, it will have serious consequences for users. It is particularly important to ensure that the products are correctly labeled and traceable from donor to recipient.

Article 2 [Risk Control Strategy] According to the particularity of cell therapy products, enterprises shall conduct risk assessment on the products and the entire process from the receipt of donor materials to the storage and transportation of finished products, and formulate corresponding risk control strategies to ensure the safety, effectiveness and quality control of the products.

Article 3 [Biosafety] Enterprises shall establish biosafety management systems and records, have facilities and equipment to ensure biosafety, prevent and control biosafety risks in the product production process, and prevent the introduction or spread of pathogens.

Specific news link: Food and Drug Inspection Center publicly solicits opinions on the "GMP Appendix - Cell Therapy Products" (Draft for Comments)