REGENERATIVE MEDICINE SERVICES

REGENERATIVE MEDICINE
SERVICES

RAPID provides services for various applications and procedures for medical institutions that need preparing of regenerative medicine provision plan. Japan has two laws regulating its regenerative medicine market: Act on the Safety of Regenerative Medicine (ASRM) and the revised Pharmaceutical Affairs Act (PMD Act), we provide regulatory support for medical institutions want to enter a new field of regenerative medicine business.

FEATURE

RAPID provides support for foreign or domestic market entry in Japan, with expertise in navigating Japan’s challenging regulatory environment.
It is also possible to get regulatory application approval for regenerative medical products. We will help you to get over that process smoothly and quickly as your marketing authorization license holder (DMAH).
Our specialized team will offer consultation with quick response and secure pricing.
Please feel free to contact us for consultation and quotation.

Regulatory application for regenerative medical related products and imports your products in Japan

For more information, please visit Medical Device Development Services

: Preparation of provision plan of Class Ⅱ / Class Ⅲ regenerative medicines (It will take 1~2 months)

Preparation of partial application / Notification of Specific Processed Cells Manufacture
150,000 yen〜
Making all application
500,000 yen〜

: Support for periodic reports after approval

100,000 yen〜

SERVICE

Provision Plan of Class Ⅱ / Class Ⅲ Regenerative Medicine

Regenerative medicine using stem cells is strictly reviewed by Certified Committee for Regenerative Medicine approved by Ministry of Health, Labor, and Welfare (MHLW) for validity, safety, physician system and cell processing management system of the treatment. RAPID provides services for partial or all of the documents to start the regenerative medicine business.

Preparation of provision plan of class Ⅱ Regenerative medicine=Somatic stem cells products
Preparation of provision plan of class Ⅲ Regenerative medicine=Somatic cells
Preparation of notification of Specific Processed Cells Manufacture

Support for After Approval

After regenerative medicine provision plan has been approved, procedures will be required when periodic reports and changes occur. RAPID will prepare the necessary documents for various procedures after the start of the business.

Periodic provision status report (A report is required to be submitted every year)
Change review (Committee review required)
Minor changes (No need for committee review)
Report on disease outbreak (It may be required review by committee)
When stopping the provision of regenerative medicine (No need for committee review)

Regenerative Medicine

Along with “Law on Securing Quality, Efficacy, and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (Pharmaceutical and Medical Device Act)”, Law on ensuring the safety of Regenerative Medicine (Act on the Safety of Regenerative Medicine) has been enacted in November 2014, procedures for ensuring safety of regenerative medicine, etc. and rules for outsourcing cell culture processing, etc. have been established.

It is mandatory to submit a provision plan of regenerative medicine etc. according to the risk to the Minister of Health, Labor and Welfare.
If a medical institution has a Specific Processed Cells Manufacture or Cell Processing Center for treatment in its own hospital, it must be submitted the notification to the Minister of Health, Labor and Welfare.
Providing regenerative medicine without submitting a provision plan would constitute a violation of the law.