What is a regenerative medicine products?
Classification under the Pharmaceutical and Medical Device Act

A regenerative medicine product uses cells or genes for the treatment or prevention of diseases or injuries. The scope of regenerative medicine products defined under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act) is as follows:

• 1.Products in which cells from humans or animals have been cultured or otherwise processed, with the purposes of:
  a. Reconstruction, repair, or formation of the structure or function of the body of humans or animals.
  b. Treatment or prevention of diseases in humans or animals.
• 2.Products intended for the treatment of diseases in humans or animals that involve the introduction of genes into human or animal cells to express them in the body.

regenerative medicine products are classified separately from drugs and medical devices under the Pharmaceutical and Medical Device Act (commonly known as the PMD Act). Since regenerative medicine products involve the use of live cells or viruses themselves as products, specialized manufacturing and quality control different from those for drugs and medical devices are required.

Difference Between “Products” and “Medical Care” in Regenerative Medicine

In regenerative medicine, the applicable regulations differ depending on whether regenerative medicine products are provided by companies or medical care is offered within medical institutions. The former must comply with the Pharmaceutical and Medical Device Act (PMD Act) and adhere to the Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP) ordinance, requiring appropriate manufacturing facilities and stringent manufacturing and quality control. On the other hand, the latter is subject to theAct on Securing Safety of Regenerative Medicine, under which clinical research or private medical practice must be conducted.

 

CM Plus’s Support for Regenerative Medicine Products

Steps from Development to Manufacturing and Sales of regenerative medicine products, etc.

CM Plus support our clients through every phase, from the basic research to post-marketing of regenerative medicine products, etc.

 

CM Plus can help you if you want to:

• Consider entering the regenerative medicine industry from a different field.
• build an organization that complies with GCTP.
• scale up equipment from lab scale to commercial scale and need support for equipment selection and specification decisions.
• create documents that comply with the recent risk-based approach.
• advice on whether to own a CPC facility in-house or to outsource it.
• perform validations and create SOPs for production but lack internal resources.
• conduct a GAP analysis to check if your facilities meet the latest regulatory requirements.
• someone to accompany you for pre-consultations and inspections with regulatory authorities.
• rent a lab and install equipment, and need to plan a layout that complies with GCTP, etc.

What CM Plus Regenerative Medicine Consulting service can do

• CM Plus have consultants in various fields. In the field of regenerative medicine, we can provide one-stop solutions for your needs by integrating consulting and engineering services. Whether it’s regulatory submission strategies in the research and development phase, GCTP organizational structures, or CPC facility planning in the manufacturing phase, we have the expertise to support you.

One-Stop Service for Regenerative Medicine by CM Plus

Our highly experienced regenerative medicine consultants and engineers provide services tailored to your specific needs.

 

QMS/GCTP Consulting

-Support for building QMS and GCTP compliant organizations
-GCTP education support
-Supplier management support
-GAP analysis and inspection support

Profiles of Regenerative Medicine Specialists

Profiles of GMP/GCTP Consultants

Regulatory Affairs Consulting

-Support for creating development plans
-Support for various consultations with the Pharmaceuticals and Medical Devices Agency (PMDA)
-Support for obtaining manufacturing and marketing authorizations/manufacturer’s licenses/foreign manufacturer certifications (including responding to inquiries)
-Preparation of approval applications and related documents

Profiles of Regulatory Affairs Consultants

Facility and Equipment Diagnosis/Construction Support

-Facility design support including basic plans and basic designs for GPC facility construction plans
-Support for equipment selection and specification creation when introducing production equipment
-Construction management during CPC facility construction

Profiles of Engineering Consultants

Validation Support

-Support for creating validation documentation when introducing equipment
-Creation of various SOPs
-Validation management tasks

Profiles of Validation Consultants

Foreign Language Support

-Support for cross border factory construction projects
-Support for obtaining foreign manufacturer certifications
-Dispatch of interpreters for cross border inspections
-Support for the preparation of English documentation

Profiles of International Business Consultants

Profiles of Interpreter and Translator Consultants

Example of Solving Your Concern ①
(For Regenerative Medicine Companies)

We are starting a regenerative medicine business. We have a rough schedule, but we don’t know where to start when it comes to obtaining marketing authorization, manufacturing and marketing licenses, GCTP compliance confirmation, and organizational structure building.

For cliants with such concerns, CM Plus can provide the following support:

Drafting a Roadmap for Regenerative Medicine Business and Development Plans

When launching a regenerative medicine business, it is crucial to have a well-designed roadmap (master schedule) that comprehensively covers all necessary procedures and investigations in a carefully planned order. Creating this roadmap requires a high level of expertise and experience, making the involvement of experts with knowledge of regulatory affairs, QMS, and development experience in pharmaceuticals and regenerative medicine essential. CM Plus has many consultants specializing in the field of regenerative medicine, regulatory submissions, and QMS construction. We can support you in organizing each step—from basic research, non-clinical trials, clinical trials, quality tests, marketing authorization, manufacturing and marketing licenses, GCTP compliance, and foreign manufacturer certifications—and in drafting and planning your roadmap.