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Frequently Asked Questions (FAQ)

 

Application for Product Approval

Q1-1
I would like to know about Japanese approval system for pharmaceuticals / medical devices.

Please refer to this page.

Q1-2
Does PMDA provide or recommend any English-language publications that may be helpful for becoming familiar with regulations concerning drug, medical device, and regenerative medicine products in Japan?

As PMDA is an independent administrative institution, it must maintain a neutral and impartial position, and as such PMDA is unable to recommend any particular company or publication. PMDA only provides information related to official government publications released by MHLW. You may find a tentative English translation of The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices on this website administered by the Ministry of Justice. However, only the original Japanese text of this law shall have legal effect, and this translation is to be used solely as reference material to aid in the understanding of this law.

Q1-3
Will PMDA provide a list of Japanese Marketing Authorization Holders?

PMDA is NOT able to provide specific information such as a list of Marketing Authorization Holders. For your information, we only provide a link page including Japan's pharmaceutical and medical device manufacture association which Japanese Marketing Authorization holders belong to at.

Q1-4
Can we file our application for product approval to PMDA in a language other than Japanese?

No, PMDA does not accept applications in other languages. Japan's Pharmaceutical Affairs Law requires all forms related to the marketing application to be submitted in Japanese.

Q1-5
What is the classification for application of the product in Japan (Pharmaceuticals, Quasi-drugs, Cosmetics, Medical devices or other than PAL) ?

The procedure for classification varies according to each product. For this reason, the Ministry of Health, Labour and Health is able to assist with questions related to the product. When you go through the necessary formalities related to PAL, you should confirm the procedure with the designated marketing authorization holder.
Additional information can be found on MHLW's website.

Post-marketing Safety

Q2-1
I would like to know how to submit post-marketing safety reports of drugs and medical devices (i.e., Individual Case Safety Reports [ICSRs] and Periodic Safety Update Reports [PSURs]). Does the PMDA accept reports written in English?

Please refer to the following URL to see the notices regarding adverse reactions or malfunctions reporting:
Drugs (only in Japanese language)
Medical devices (only in Japanese language)

A Marketing authorization holder which distributes a drug or a medical device in Japan is required to submit post-marketing ICSRs and PSURs. (If a drug or medical device is foreign-manufactured under foreign exceptional approval, an appointed marketing authorization holder is required to submit post-marketing ICSRs and PSURs.)

Please be noted that ICSRs and PSURs should be written in Japanese language, except some specific items in the both reports. Please see detailed information in the above notices.

Q2-2
I would like to search or download information about case reports on suspected adverse drug reactions (ADRs) and malfunctions. I prefer the information in English, if available.

Please refer to the following URL to see information about case reports:
Drugs
Medical devices

Regarding case reports on suspected ADRs, you can search the information on the website or download the information as a comma separated value (CSV) file from the website. As to case reports on suspected malfunction, you can search the information on the website, but the CSV format of the information is not available.

The information about case reports on suspected ADRs and malfunctions is available only in Japanese language.

Q2-3
I need a package insert of a certain drug (or a medical device).

Please refer to the following URL to find a package insert:
Drugs
Medical devices

Package inserts are available only in Japanese language.

Q2-4
I would like to learn about post-marketing pharmacovigilance for drugs and medical devices in Japan.

Please refer to this page regarding safety measures in Japan:

Acceptance of Medical Device Foreign Clinical Data

Q3-1
Can I submit foreign clinical data based on the clinical studies conducted outside of Japan for Marketing approval for medical devices in Japan?

Yes, PMDA accept and review foreign clinical data of medical devices which are applied for Marketing approval in Japan. Please see relevant notifications:
- "Handling of the data of clinical studies for medical devices conducted in foreign countries (March 31, 1997, YAKUHATSU No. 479) (English)"
- "Handling of clinical study data on medical devices which was carried out in foreign countries (March 31, 2006, YAKUSHOKUKIHATSU No.0331006) (English)"

The past record of the number of foreign clinical data of medical devices PMDA has accepted is shown below.

Number of Medical Devices Approved with Clinical Data Review

  2006 2007 2008 2009 2010
*
2011
*
Foreign Clinical Data Only 22 20 26 32 29 38
Both Foreign and Japanese Clinical Data 2 4 2 6 2 5
Japanese Clinical Data Only 18 24 14 14 19 14

*: Additionally, 2 medical devices (in FY 2010) and 15 medical devices (in FY 2011) have been approved with clinical evaluation reports.
(Source: PMDA Annual Report FY2010 Supplementary Information (Japanese) )

You can also see the details of approved medical devices including the source of clinical data in PMDA annual reports, for example, "Table 2. Products Approved in FY 2010: New Medical Devices" in "PMDA Annual Report FY2010 (English)".

Accreditation of Foreign Manufacturers

Q4-1
Please tell me about an overview of Japanese accreditation of foreign manufactures.

Please refer to this page.

Q4-2
My manufacturer has already obtained the accreditation of foreign manufactures in Japan, but has no certificate at hand. To whom shall I ask?

Please contact your agent/proxy application company in Japan. The accreditation certificate is sent from PMDA to your appointed agent/proxy company. If you need to reissue of the certificate, it is also recommended to contact your agent/proxy application company first.

Q4-3
How can I renew/change my accreditation of foreign manufactures?

Please process the renewal/change of the accreditation of foreign manufactures via your appointed agent/proxy application company in Japan.
Please refer to this page for the details regarding renewal/change of the accreditation of foreign manufactures. (available only in Japanese)

Q4-4
How can I check the expiration and renewal status of my accreditation of foreign manufactures?

Please check the accreditation list provided on this page.
The expiration date and the status of the application of renewal of the current accreditation can be found on the list. If an "Application for Renewal of Accreditation" has been received by PMDA, open circle (circle) is indicated.

Master File System

Q5-1
I would like to know about an outline of the drug master file (DMF) system.

Please refer to this page.

Q5-2
It should be published and/or posted on the PMDA website so that the foreign manufactures would be able to understand the PMDA confidentiality policy.

The provisions concerning confidentiality obligations are prescribed under the Articles 13 and 42 in Act on Pharmaceuticals and Medical Devices Agency, Independent Administrative Agency. The act is published only in Japanese at present. It is not a government publication material but is useful as reference. (ISBN: 978-4-8407-3999-3)

the Articles 13 in the Act on PMDA (Responsibility to Maintain confidentiality).
The executives, personnel or persons who formerly held such positions in the PMDA shall not leak or make fraudulent use of secrets learned during their work.

the Articles 42 in the Act on PMDA.
Persons violateing the provisions of Articles 13 shall be subject to penal servitude of one year or less or a fine of 1,000,000 yen or less.

 

Q5-3
Is there a list of approved DMFs (APIs) available for the industry to view on the PMDA website?

Manufactures of APIs can voluntarily register DMFs without any review by PMDA. Each DMF is not reviewed alone, but reviewed in the process of product review.
Information on whether or not an individual DMF was referenced in an application for a drug product is not available for disclosure.
Only a list of registered DMFs is disclosed. (available only in Japanese)

JCN 3010005007409

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Frequently Asked Questions (FAQ)
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