2024年4月14日发(作者：鼠标左键失灵右键正常)

Application for Accreditation of Foreign Manufacturers

(This English document is only for reference purpose. In case of any discrepancy, the Japanese

text shall prevail. For further information, please contact Ministry of Health, Labour and Welfare

(MHLW) or PMDA.)

1. What is Accreditation of Foreign Manufacturers?

A foreign manufacturer (a person/a company) intending to manufacture drugs,

quasi-drugs, or medical devices in foreign countries and export them to Japan, is

required to be accredited by the Minister of Health, Labour, and Welfare as an

“Accredited Foreign Manufacturer”, specified in Article 13-3 of PAL, in the same way

that a Japanese manufacturer is licensed. The person or the company who intends to

apply for the accreditation is hereinafter referred to as an “Applicant”.

However, a foreign manufacturer of the drug or medical device, etc. whose marketing

approval holder has an effective importing license granted under the old PAL as of April

1, 2005, is deemed to be temporarily accredited under the revised PAL by the end of its

effective period. The manufacturer satisfying the above condition is hereinafter

referred to as a “Deemed Accredited Foreign Manufacturer”.

In addition, a foreign manufacturer intending to manufacture only drug substances to be

exported to Japan also need to obtain accreditation as an “Accredited Foreign

Manufacturer”. The Minister of Health, Labour and Welfare has an authority to grant

accreditation to a foreign manufacturer, while PMDA examines buildings and facilities of

the manufacturing establishment for accreditation. The accreditation is granted for

each manufacturing establishment according to the category specified by the

Enforcement Regulations.

Before applying for accreditation, a Japanese marketing approval holder for an

“Applicant” needs to submit “Business Number Registration Form”, reporting information

on the applicant’s business and manufacturing establishments, in order to obtain

“Business Number”.

2. Application for Accreditation of Foreign Manufacturers

(1) An “Applicant” is required to submit “Application for Accreditation” (Form No. 18 in

the PAL Enforcement Regulations) that is addressed to the Minister in duplicate,

and “Application for Accreditation Examination” (Form No.16-(2) in the Regulations)

to Chief Executive of PMDA. Both applications need to be submitted to

Administration Division II, Office of Review Administration of PMDA.

A Japanese marketing approval holder who markets drugs and medical devices, etc.

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manufactured by a foreign manufacturer can make an accreditation application on

the manufacturer’s behalf. However, the space of “Name of Applicant” on the

application form should be filled out with the foreign manufacturer’s name (when an

“Applicant” is a corporation, names of the corporation and their CEO). In addition,

an “Applicant” is to be responsible to renew their accreditation every 5 years. For

more details on the renewal procedure, please refer to 2-(4), “Application for

Renewal of Accreditation of Foreign Manufacturers”.

Examination Fees for the accreditation differ between on-site and document

examinations. However, PMDA requires only document audit fee to be paid to our

bank account because, in principle, we do not conduct on-site inspection only for the

purpose of examining buildings and facilities of a foreign manufacturing

establishment to be accredited.

A target period to complete administrative processing (standard administrative

process time) of accrediting a foreign manufacturer is not specifically set. However,

the period can be estimated to be about 5 months because the Minister’s licensing

process for a domestic manufacturing establishment takes about 5 months.

When an “Applicant” intends to apply for a new accreditation, they cannot apply for

multiple categories in one accreditation application. They need to submit an

accreditation application for one category and, at the same time, submit additional

applications for the other categories (ref. 2-(3), Application for Change/Addition in

Category of Accreditation of Foreign Manufacturers).

(2) Documents to Be Attached to Accreditation Application (Article 35, Paragraph

2 of the PAL Enforcement Regulations)

① ”A medical certificate from a physician which indicates whether or not an “Applicant”

has mental disorders or is addicted to narcotics, cannabis, opium or stimulant drugs”.

(When the “Applicant” is a corporation, medical certificates of their CEO and all the

executives responsible for the services are required.)

A medical certificate and the other required documents for accreditation can be

written in any language, but their Japanese translations are required. The

reference of translator is needed only when they are written in other languages than

English.

When the “Applicant” is a corporation, and the Minister of Health Labour and

Welfare recognizes that the above medical certificate form a physician is not an

absolute necessity taking the responsible services of the executives into

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