Please refer to this page.
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.
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.
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.
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.
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.
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.
Package inserts are available only in Japanese language.
Please refer to this page regarding safety measures 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
|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)".
Please refer to this page.
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.
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)
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 () is indicated.
Please refer to this page.
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.
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)