About New Japanese Regulatory framework

To provide the public with fast, safe access to regenerative medicine, the Act on the Safety of Regenerative Medicine, and the “Pharmaceuticals and Medical Devices Act” (“PMD Act”) were enacted on November 25, 2014. In compliance with these regulations, MEDINET will support clients use of processed cells in patient care as well as client development and commercialization of regenerative medical products.

The Act on the Safety of Regenerative Medicine

Under the new framework, specific risk-related procedures are determined by Japan’s Ministry of Health, Labour and Welfare (“MHLW”) to promote safe, ethical regenerative medical treatment. MHLW also requires medical institutions to submit regenerative medicine provision plans to certified committees for approval and further submission to MHLW. In addition, the framework allows medical institutions to commission cell processing from MHLW-licensed manufacturers of specified cell products.

  • Outsourced cell processing by authorized manufacturers of specified cell products is permitted.
  • Any entity engaged in regenerative medicine and cell therapy in Japan must comply with government standards.

3 classes Risk-Dependent Procedure

Example of target tissues or cells
Example of target tissues or cells

Revision based on briefing materials of the National Meeting of the Directors from Health,
Labour and Welfare-Related Bureau of the Ministry of Health, Labour and Welfare

The Act on Pharmaceuticals and Medical Devices

To promote the development and provision of safe, effective regenerative medical therapies and products, the PMD Act revises the Pharmaceutical Affairs Act in accordance with the characteristics of regenerative medical products (defined as products distinct from pharmaceutical and medical devices and not defined as specified cell products under the Act on the Safety of Regenerative Medicine). In addition, the Act permits rapid marketing authorization of regenerative medical products.

  • A new category, Regenerative medical products, was established in addition to the existing Pharmaceuticals and Medical Devices categories.
  • The expedited approval system for regenerative medical products, with conditions and a limited term, was introduced.

Expedited approval system under the PMD Act

Expedited approval system under the PMD Act
Post-marketing safety measures are required,
including prior informed consent of risk from patients

Revision based on briefing materials of the National Meeting of the Directors from Health,
Labour and Welfare-Related Bureau of the Ministry of Health, Labour and Welfare

Regenerative medical products utilize the patient’s own unique cells, which makes verification of efficacy highly time-consuming.
To address this challenge, an expedited approval system (subject to conditions and a limited term) was introduced that allows conditional marketing approval while trials are being conducted, thus shortening the time to commercialization.

Japan’s new framework is welcomed by entities developing medical technologies using processed cells as well as enterprises seeking to develop and commercialize regenerative medical products. As a leader in CDMO with regulatory compliance,
MEDINET provides its clients with innovative solutions of the highest quality and efficiency.

Information concerning regenerative medicine regulations is current as of November 25, 2014, and may not reflect more recent information.