T-22: Current Trends in Global Regulations of Human Cells and Tissue Products
Taiwan Shionogi & Co., LTD Taiwan
Each country has its own regulation framework because of different national situation. This poster will give overview of regulations and regulatory authorities, review committees and their regulatory framework for human cells and tissue products in many countries and regions.
We survey and collect the regulations of human cells and tissue products in different countries to explore the international legal regulatory harmonization by comparing national approaches.
Human cells and tissue products are new therapies to be intended to treat disorders, and are expected to enable the regeneration of tissue or organ specific functions. They have been classified and defined such as Human Cells, Tissue, and Cellular and Tissue-based Products (HCT/Ps) in the United States, as Advanced Therapy Medicinal Products (ATMPs) in the European Union, and as regenerative medicine products in Japan. Moreover, legislation of the development and management of human cell-based products are quite different in many regions. For example, in the US, HCT/Ps are under sections 351 and 361 of the Public Health Service (PHS) Act (42 the United State Code) according to Title 21, Part 1271.10 and 1271.20 in the Code of Federal Regulation (21CFR1271). AMTPs are regulated as the somatic cell therapy medicinal product and the tissue engineering product under Regulation (EC) No 1394/2007 of the European Parliament and the Council in the EU. In contrast, Japan had adapted existing legislation under clause 2 of the Pharmaceutical Affairs Law (PAL). The revised PAL is reformed the category of human cells and tissue products to “regenerative medicine products.”
Currently, Taiwan has announced “Guidance of Investigation of Human Cell Therapy Products” for the regulatory requirement of clinical trials for cell therapy products. “Guidance of Regulations for Registration of Human Cell Therapy Products” illustrates the review considerations of new application. In an increasing demanding regulatory environment, we are drawing up the Act to regulate human cell-based products in order to accelerate the application in Taiwan.
Regulations of human cells and tissue products are varied between countries and also between different types of products. In view of the characteristics of cell therapy products are different from small molecule or biological drugs, a specialized Act of flexible quality management regulatory framework is what all we want. Taiwan Food and Drug Administration analyses the regulations to understand their concerns. According to the above, specific legislation to focus on the management of human cell and tissue products will be announced in Taiwan soon.