Japan Law2017-07-31T16:58:59+00:00

Japan Leads the Forefront of the Regenerative Medicine Industry

Japan has become the most favorable environment for regenerative medicine after changes to its national laws in November of 2013.

The Japanese legal approval process for novel therapies was shortened to be world’s fastest, designed specifically for expedited treatment and trials of regenerative medical therapies.

Consequently, the Japanese market for regenerative treatment is now projected to experience rapid growth and to be worth US$12.7 Billion by 2030.

Why other nations should follow the example of Japan:

The new Japanese legal framework secures prompt and safe application of therapies in the regenerative medicine pipeline.

After a new therapy is shown to be safe, it undergoes expedited approval through the revamped legal system; the therapy then remains in “conditional approval” status while clinical trials are ongoing.

Japan’s laws are designed for biological products (processed cells and tissue) in the treatment of patients, for the repair and regeneration of tissue.

Following the changes in Japan’s laws, medical research companies have flocked to Japan where they are establishing laboratories and clinics.

The rest of the world would benefit by following Japan’s example.

Such laws:

  • foster an intellectual and cultural atmosphere that’s friendly to scientific and medical progress,
  • allow for the legal treatment of patients suffering from conditions that would benefit from adult stem cell therapy, in a safe and expedited manner,
  • attract international researchers and medical companies,
  • provide greater opportunities for local researchers,
  • increase collaboration between university research centers, medical clinics, and the business community,
  • act as a magnet to draw patients from around the world and to promote their treatment with much-needed therapies,
  • strengthen the health of local domestic economies and grow the national GDP.

By contrast, click here to read about U.S. FDA laws.