Japan.

The Pharmaceutical Affairs Law of Japan requires a license for marketing authorization when

importing to Japan and selling pharmaceutical products manufactured in other countries.

To receive a license for marketing authorization, the manufacturer/seller must, at the very

least, employ the following personnel full time: a General Manufacturing and Marketing Officer, a

Quality Assurance Officer, and a Safety Management Officer.

A license for marketing authorization may not be granted if the quality management meth-

parties who have not received licenses for marketing authorization when importing pharmaceuticals

from other countries.

However, the first purchaser of the pharmaceutical product in Japan must be the license for

marketing authorization holder. Schemes in which the party entrusted with import services initially

purchases the pharmaceutical product and then sells it to the license for marketing authorization

holder are not allowed.

In addition to the license for marketing authorization, a manufacturing license may be re-

quired in the event that the party entrusted with import services makes substantive modifications to

the pharmaceutical product’s packaging or labeling or temporarily stores the pharmaceutical product.

As a condition to receiving a manufacturing license, there must be a full-time pharmacologist

in each manufacturing location who serves as the Pharmaceuticals Manufacturing Manager (Manag-

ing Pharmacist). In addition, the structure and facilities at the location must satisfy criteria stipulated

in the ordinances promulgated by the Ministry of Health, Labour and Welfare.

The manufacturing license is issued by the governor of the prefecture in which the manufac-

turing location is located except in cases requiring particularly high levels of expertise.

To manufacture pharmaceutical products, a license for marketing authorization holder must

also obtain a manufacturing license. A license for marketing authorization holder may entrust all

manufacturing of the pharmaceutical product to a third party, but the party entrusted with manufac-

ture must obtain a manufacturing license.

foreign location at which pharmaceutical products are manufactured, and in actual practice, foreign

manufacturers are required to obtain this accreditation.

Parties engaged in manufacture/sale must in principle receive the approval of the Minister

of Health, Labour and Welfare for the manufacture and sale of each pharmaceutical product to be

manufactured and sold (including import sales) in Japan.

Notwithstanding, approval may be revoked in the event of problems with the efficacy or

safety of a pharmaceutical product after it has been approved.

enterprises located in foreign countries may apply for manufacture and sale approval from outside

manufacture and sale in Japan may nominate a party to conduct manufacture/sale in Japan and

seek approval from the Minister of Health, Labour and Welfare for manufacture and sale by that

party. The party nominated to manufacture and sell the pharmaceutical must obtain a license for

products.

The advertising of pharmaceutical products must be within the scope of the pharmaceutical

product’s indications. Both false and exaggerated advertising are prohibited.

The pharmaceutical manufacturer/seller and the party obtaining approval under foreign

country exceptions are required under the Pharmaceutical Affairs Law to collect and investigate

information on side effects and infections resulting from the pharmaceutical product. Reports must

be filed with the Minister of Health, Labour and Welfare in the event that an objective assessment of

the information obtained indicates that the pharmaceutical product meets certain criteria stipulated

in the ordinances promulgated by the Ministry of Health, Labour and Welfare.

The Pharmaceutical Affairs Law of Japan requires a license for marketing authorization when

importing foreign-manufactured medical devices into Japan for sale. Licenses are issued according to

risk category, as outlined in the previous section.

A license for marketing authorization may not be granted if the medical device’s quality

management methods and postmarketing safety management methods fail to conform to standards

stipulated in the ordinances promulgated by the Ministry of Health, Labour and Welfare.

As with pharmaceutical products, a license for marketing authorization holder may entrust

import services to third parties who have not received licenses for marketing authorization when

However, the first purchaser of the medical device in Japan must be the license for marketing

authorization holder. Schemes in which the party entrusted with import services initially purchases

the medical device and then sells it to the license for marketing authorization holder are not allowed.

manufacturing license for each category of medical device. In this case, the applicable categories

include “Sterilized Medical Devices”; “Nonsterilized Medical Devices”; “Medical Devices Only

Packaged, Labeled, or Stored”; and “Biologically Derived Medical Devices.”

To manufacture medical devices, a license for marketing authorization holder must also ob-

tain a manufacturing license. A license for marketing authorization holder may entrust all manufac-

turing of the medical device to a third party, but the party entrusted with manufacture must obtain a

manufacturing license.

Parties that receive manufacturing licenses may be held criminally accountable and/or may be

subject to administrative disposition, including cancellation of licenses, in the event of violations of

the Pharmaceutical Affairs Law.

As with pharmaceutical products, the Pharmaceutical Affairs Law stipulates that when

approval for each item from the Minister of Health, Labour and Welfare for all Highly Advanced

Controlled Medical Devices and also for Controlled Medical Devices when the Minister of Health,

Labour and Welfare has not created certification standards. Notwithstanding, approval may be

revoked in the event of problems with the efficacy or safety of a medical device after it has been

approved.

Controlled Medical Devices for which the Minister of Health, Labour and Welfare has cre-

ated certification standards do not require manufacture and sale approvals but must be certified by a

third-party registration institution.

enterprises located in foreign countries may apply for a manufacturing and sale approval from

outside of Japan by nominating a manufacturer/seller in Japan and causing the manufacturer/seller to

manufacture and sell the medical device. The party nominated to manufacture and sell the medical

devices must obtain a license for marketing authorization and must discharge all responsibilities as a

medical devices.

As with pharmaceutical products, the advertising of medical devices must be within the scope

of the medical device’s indications. Both false and exaggerated advertising are prohibited.

The medical device manufacturer/seller and the party obtaining approval under foreign

country exceptions are required under the Pharmaceutical Affairs Law to collect and investigate

information on the efficacy and safety of the medical device. Reports must be filed with the Minister

of Health, Labour and Welfare in the event that an objective assessment of the information obtained

indicates that the medical device experiences malfunctions and accidents that meet criteria stipulated

in the ordinances promulgated by the Ministry of Health, Labour and Welfare.