Regenerative medicine Manufacturing & Sale

The new regulations (after 25th Dec, 2014) can be summarized as follows.

《Enforced from 25th Dec, 2014》
License is required for manufacturing and selling regenerative medical products.
Manufacturing and selling regenerative medical products should be approved MHLW (Ministry of Health, Labour and Welfare).
※ Special approval for regenerative medical products
If a product matches one of the following cases, and never violates the regulations about regenerative medical products, regardless of 2nd, 5th, 6th, and 8th paragraphs of article 23, special approval under the agreement of pharmacist/food hygiene council.
A product should be urgently used to prevent spread of disease or unexpected damages related to human health, which can cause seriously negative impact on people’s life and health, and no alternative except this product should be available.
Usage of a product should be accredited for its selling or providing, or being stored or distributed in purpose of selling or providing in foreign countries (indicating a country which has approval procedures or regulations on product quality, validity, and safety, corresponding to our country).
(28th paragraph of article 23 in pharmaceutical and medical devices law (special approval))
The regenerative medical product is defined in the revised pharmaceutical law, which includes new concepts of quality, validity, and safety of drug and medical devices.
The regenerative medical product can be defined as follows
(in compliance with paragraph 9 of article 2)

  1. A product containing materials cultivated for human or animal cells in purpose of medical treatment

    or veterinary treatment, of which cases can be defined as follows

  2. A product which regenerates physical organ of human or animal including its function

  3. A product which cures or prevents a disease of human or animal

  4. A product, which cures a disease of human or animal, and also include a gene, which can result

    in transfection in a body

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