There are 28 regenerative medicine products approved in Japan | What becomes visible when you count them

The term “regenerative medicine” is now something we see almost every day in advertisements and articles.

So, how many “regenerative medical products” do you think have actually received national approval in Japan?

28

According to the Regenerative Medicine Portal, 28 products as of August 31, 2026.

Does that seem like many, or few?

This is the number after more than 10 years since the system was created. At the very least, we can see that it is not “a now-commonplace technology.”

Divided into four types

Approved products are generally divided into the following categories.

• Processed human somatic stem cell products (products that use mesenchymal stem cells, corneal epithelial stem cells, and the like)
• Processed human somatic cell products (products made by collecting and processing the patient’s own cells)
• Processed human induced pluripotent stem cell (iPS) products
• Gene therapy products (products that use viral vectors, and the like)

Among these, iPS cell-derived products number 2. The category best known from the news is, in fact, the smallest in number.

Most recently, a new product was approved in June 2026. The number is still growing.

Why is this a separate framework from “pharmaceuticals”?

With the 2014 legal amendment, Japan created an independent category called “regenerative medical products.” created.

The reason is that products using cells do not have uniform contents from one person to another. Unlike chemically synthesized drugs, they cannot be defined as “this molecule in this many mg.”

So, a system was created to grant approval first, with time limits and conditions, once a certain level of efficacy has been presumed and safety has been confirmed.

Delivering quickly, and verifying properly. This framework is designed to make both possible.

This is a different world from cosmetics

Let us make this clear.

All 28 of these products are used in medical settings. Not a single cosmetic product is included among them.

What cosmetics called “human stem cell cosmetics” use is culture medium (liquid components including the supernatant), not the cells themselves.

About this boundary, “Human stem cell cosmetics are not regenerative medicine” explains it in detail.

Even when the same words are used, their legal position is completely different. We believe that not mixing up this point is the minimum responsibility of anyone handling this field.

References: Regenerative Medicine Portal, “Information on Regenerative Medical Products” (as of August 31, 2026); Pharmaceuticals and Medical Devices Agency (PMDA), “List of Approved New Regenerative Medical Products”; Ministry of Health, Labour and Welfare

※This article introduces system information published by public institutions and is not intended to diagnose, treat, or prevent any specific disease.

—The Value Village Editorial Team