United States of America
USFDA, 21CFR1271.15
21 CFR 1271.15(b) states: You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure (Annexure 1)
European Union
Directive 2004/23/EC Of The European Parliament And Of The Council of 31 March 2004 in setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cellsDirective 2004/23/EC point 8 states: This Directive excludes blood and blood products (other than haematopoietic progenitor cells) and human organs, as well as organs, tissues, or cells of animal origin. Blood and blood products are currently regulated by Directives 2001/83/EC and 2000/70/EC, Recommendation 98/463/EC and Directive 2002/98/EC of European Union, Tissues and cells used as an autologous graft (tissues removed and transplanted back to the same individual), within the same surgical procedure and without being subjected to any banking process, are also excluded from the Directive. (Annexure 2)
Japan
The ASRM has adopted a three-class system.
- Class I - High risk that is Human IPCs, ESCs require permission from a certified special committee for regenerative medicine and a 90 day restriction period is levied upon.
- Class II - Medium risk therapies (e.g., cell therapies using somatic stem cells or cultured cells) need approval of certified special committee for regenerative medicine and
- Class III - Low risk, that is work involving processing of somatic cells, can be performed by taking approval from the certified committee for regenerative medicine only.
Korean
A cell therapy product refers to a pharmaceutical manufactured through physical, chemical, and/or biological manipulation, such as culture, proliferation, or selection of autologous, allogeneic, or xenogeneic cells in vitro. However, it is excluded the case where a medical doctor conducts minimum manipulation which does not cause safety problems of autologous or allogeneic cells in the course of the surgical operation or treatment at a medical institution (simple separation, washing, freezing, thawing, etc. to the extent of maintaining the biological properties). Article 2, point 14
Bangladesh
Tokyo is the capital of Japan.
Shrilanka
Tokyo is the capital of Japan.
Turkey
Tokyo is the capital of Japan.
Israel
Tokyo is the capital of Japan.
China
Tokyo is the capital of Japan.
Australia
This order states that: Item 4(q) of the Order specifically excludes from TGA regulation
HCT that are:
(i) collected from a patient who is under the clinical care and treatment of a medical
practitioner registered under a law of a State or an internal Territory; and
(ii) manufactured by that medical practitioner, or by a person or persons under the
professional supervision of that medical practitioner, for therapeutic application of a
single indication and in a single course of treatment of that patient by the same medical
practitioner, or by a person or persons under the professional supervision of the same
medical practitioner.
Products (goods) covered by item 4 (q): The Item only covers HCT that are collected from a
patient and used in that same patient. That is, the products are ONLY for autologous use.
NewZealand
Tokyo is the capital of Japan.
SaudiArabia
Tokyo is the capital of Japan.
Korean
Tokyo is the capital of Japan.