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. 2022 Jul 18;13:896685. doi: 10.3389/fimmu.2022.896685

Table 1.

Government policies regarding cell therapies worldwide.

Region Agency in charge Government policy Year of promulgation Definition Classification Reference
European Union EMA (European Medicines Agency) Guideline on Human Cell-Based Medicinal Products (Doc. Ref. EMEA/CHMP/410869/2006) 2008

  1. The European Medicines Agency’s scientific guidelines on cell therapy and tissue engineering help medicine developers prepare marketing authorization applications for human medicines.

  2. Cellular therapy products fall into the category of advanced therapy medicinal products.

  1. Human cell-based medicinal products are heterogeneous with regard to the origin and type of the cells and to the complexity of the product.

  2. Cells may be self-renewing stem cells, more committed progenitor cells, or terminally differentiated cells exerting a specific defined physiological function.

  3. Cells may be of autologous or allogeneic origin.

  4. Cells may also be genetically modified.

  5. Cells may be used alone, associated with biomolecules or other chemical substances, or combined with structural materials that alone may be classified as medical devices.

 https://www.ema.europa.eu/en/human-cell-based-medicinal-products
Japan PMDA (Pharmaceuticals and Medical Devices Agency) Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (abbreviated as the PMD Act) 2014

  1. PMDA offers consultations to give guidance and advice on clinical trials of drugs, medical devices, and cellular and tissue-based products as well as on data for regulatory submissions.

  2. Cellular therapy products fall into the category of regenerative medical products.

  1. Products intended for use in human or animal healthcare, which are obtained after culturing or other processes using human or animal cells.

  2. Products intended for use in the treatment of disease in humans or animals, which are introduced into the cells of humans or animals and contain genes to be expressed in their bodies.

 http://www.japaneselawtranslation.go.jp/law/detail_main?re=&vm=2&id=3213
United States FDA-CBER (The Center for Biologics Evaluation Research) Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products Guidance for Industry (FDA-2013-D-0576-0019) 2015

  1. CBER regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

  2. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

 Cellular therapy products include:

  1. Cellular immunotherapies

  2. Cancer vaccines

  3. Other types of both autologous and allogeneic cells for certain therapeutic indications

  4. Hematopoietic stem cells and adult and embryonic stem cells

 https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
China CFDA (China Food and Drug Administration) Technical Guidelines for the Research and Evaluation of Cell Therapy Products (Trial version, 2017-NO216) 2017

  1. Human-derived alive cell products to treat human diseases are investigated, developed, and registered in accordance with the policy of drug administration.

  2. The source, processing, and investigating clinical trials of these products meet the ethics.

  1. Cell therapy products derived from human cells are used to treat human diseases.

  2. Excluding:

  1. Blood components used for blood transfusions

  2. Hematopoietic stem cell transplantation without in-vitro treatment

  3. Reproductive cells

  4. Tissues or organs

 http://www.nmpa.gov.cn/WS04/CL2138/300457.html