18 December 2013
Practice Group(s):
Food, Drugs, Medical
Devices and
Cosmetics
Japan Enacts Regenerative Medicine Law and
Revisions to Pharmaceutical Affairs Law
By Naoki Watanabe and Ayuko Nemoto
On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety
of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the
Pharmaceutical Affairs Law (new PAL) as it applies to drugs, medical devices and
regenerative medicine. Both laws will come into effect some time within one year from
the date of promulgation. Also, on 5 December 2013, a bill to partially revise the
Pharmaceutical Affairs Law and the Pharmacists Act, which regulate online sales of
drugs (Online Sales Bill) was approved by the Diet. It will come into effect some time
within six months from the date of promulgation.
This Legal Insight analyzes the main points of these three new rules.
Regenerative Medicine Law
Summary
For the first time, the Regenerative Medicine Law sets out the definitions of regenerative
medicine and criteria for:
(i) organizations that provide regenerative medicine
(ii) manufacturers of specific cell products, and
(iii) cell culture processing facilities.
With these new rules, Japan intends to expedite the use of regenerative medicine as to
ensure the safety of such use.
New Rules Under the Regenerative Medicine Law
The Regenerative Medicine Law categorizes and regulates three types of 'Regenerative
Medical Techniques'.
First, before a medical institution provides regenerative medicine to patients for the
purpose of treatment, it is required to:
(i) submit a plan for the provision of such regenerative medicine, and
(ii) to meet the criteria regarding the provision of regenerative medicine set out in
the Ordinance of the Ministry of Health, Labour and Welfare (MHLW).
The types of regenerative medicine covered by the Regenerative Medicine Law are as
follows:
Type
Type I
Regenerative Medical
Definitions
Examples
Regenerative Medical
Techniques the effect of which is
Regenerative medicine with
induced pluripotent stem
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Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical
Affairs Law; Online Sales Bills Under Consideration
not clear or which may
significantly affect the life or
health of human beings even
with reasonable care and which
is specified in the Ordinance of
the MHLW.
Regenerative Medical
Techniques which may affect the
life or health of human beings
even with reasonable care and
which is specified in the
Ordinance of MHLW.
Regenerative Medical
Techniques other than Type I
and II Regenerative Medicinal
Techniques.
Techniques
Type II
Regenerative Medical
Techniques
Type III
Regenerative Medical
Techniques
cells (iPS cells) or
embryonic stem cells (ES
cells) products.
Regenerative medicine with
own-fat stem cells.
Traditional cancer therapy
with activated lymphocyte.
Second, the Regenerative Medicine Law enables medical institutes to outsource
processing cell cultures to companies that are not medical institutes. Pursuant to the law,
the companies processing cell cultures are subject to the regulation described below.
Types of
manufacturers
Required
process
Cell culture
processing
manufacturer
Permission
Foreign cell culture
processing
manufacturer
Cell culture processing
manufacturer with
specific cell culture
processing facilities
(eg medical institutes)
Authorization
Filing

Buildings and equipment used in the cell culture processing
facilities must meet the criteria set out in the Ordinance of
MHLW.

Cell culture processing facilities must have a staff member who
has certain biological knowledge related to the specific cell
products.

Manufacturers must comply with the criteria set out in the
Ordinance of MHLW related to manufacturing, quality
management, testing and inspection, storage, transportation,
preparation and maintenance of records and periodical reports.
Regulations
New PAL
Background
On 20 November 2013, a new law titled "Act on Assurance of Quality, Effectiveness and
Safety of Drugs and Medical Devices, etc." (the "Pharmaceuticals and Medical Devices
Act") was approved. In addition to the important changes described in our Global Food,
Drug and Medical Device Newsletter, issued in Fall 2013, the following changes will be
applicable.
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Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical
Affairs Law; Online Sales Bills Under Consideration
New Rules under the New PAL
1. Package Insert
The new PAL requires companies marketing and selling drugs, medical devices and
regenerative medical products (“products”) to provide cautions related to the use or
handling of the products based on knowledge obtained by latest articles or other
information. The part of language in the package insert is required to be filed to MHLW.
An online announcement is also required.
Who
Companies marketing and selling drugs, medical devices and regenerative
medical products.
When preparing a package insert for the products.
When
Before marketing and selling the products.
Before revising the package insert.
Must provide cautions related to the use or handling of the products based on
knowledge obtained by latest articles or other information.
Rules
A part of the language in the package insert is required to be filed to MHLW.
Online announcement is also required.
2. License Requirements for Charge-Free Lease
Companies that lease "specially controlled medical devices" (higher risk medical devices)
or certain "maintained and controlled medical devices" (which require professional
knowledge and techniques for maintenance, inspection and repairs) for free in the course
of trade must be licensed for such leasing. Currently, only a fee charging lease is subject
to license requirement but this amendment expands the license requirement to the
charge-free lease of medical devices.
Online Sales Bill
Background
On 5 December 2013, the Online Sales Bill, which would allow online sales of over-thecounter (OTC) drugs directly to consumers, was approved by the Diet.
New Regulations
The following new rules for online sales are set out in the Online Sales Bill:
Type of Drugs
Non prescription drugs
Regulations
Online sales are permitted.
Companies need to comply with new rules
including providing necessary information
to customers.
Drugs required to
be guided
Switched Drugs
(Drugs which have
been categorized as
Online sales are prohibited for a specific
period (maximum three years). Online
sales will be allowed after safety of the
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Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical
Affairs Law; Online Sales Bills Under Consideration
non prescription
drugs from
prescription drugs)
drugs is evaluated through post marketing
surveillance.
Poisons
Online sales are prohibited.
Prescription drugs
Online sales are prohibited.
On 12 November 2013, a company conducting online drug sales took legal action against
the Japanese Government, claiming that it is unconstitutional to prohibit online sales of
Prescription Drug by ordinances. We will continue to monitor new developments and any
potential revisions to regulations on online sales of these drugs.
Impact on Companies
The Regenerative Medicine Law, New PAL and Online Sales Bill will impact medical
institutes, pharmaceutical companies, medical device companies and other companies in
the medical field and we recommend that those entities review their internal rules for
compliance and educate their employees on new regulations as they come into effect.
Authors:
Naoki Watanabe
naoki.watanabe@klgates.com
+81.3.6205.3609
Ayuko Nemoto
ayuko.nemoto@klgates.com
+1.206.370.8015
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©2013 K&L Gates LLP. All Rights Reserved.
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