Q1 I would like to know about application procedures for Marketing approval for foreign Pharmaceuticals, Quasi-drugs, Cosmetics and Medical Devices in Japan.

When application are received from those who manufacture or otherwise obtain the Pharmaceuticals, Quasi-drugs, Cosmetics or Medical devices need marketing approval according to Article 14, Paragraph 1 of PAL in other countries and who intend to export them to Japan, approval is given for having each such Pharmaceuticals, Quasi-drugs, Cosmetics or Medical devices marketed by marketing authorization holders appointed by them. (foreign exceptional approval) (Article 19-2 of the PAL; PFSB Notification No.0709004, dated July 9, 2004)
Those who plan to obtain exceptional foreign approval must appoint, at the time of application, a drug marketing authorization holder according to the type of the drug to be applied for in order to have the appointed holder take various measures necessary to prevent health and sanitation problems related to the approved drug in Japan.
The drug marketing authorization holder appointed by the exceptional foreign approval holder (Designated marketing authorization holder) is authorized to market the drug irrespective of the Article 14, Paragraph 1 of the PAL, which allow only the marketing approval holder to market the product (Article 19 -2 of the PAL).
The designated marketing authorization holder shall take various procedures with the Ministry of Health, Labour and Welfare (MHLW) including the submission of applicants, notices, reports, etc. on behalf of the applicant for exceptional foreign approval or the exceptional foreign approval holder.

Q2 Does PMDA provide or recommend any publications in English to learn about Japan’s drug and medical device regulations?

As PMDA, an independent administrative institution, shall maintain a neutral and impartial position, we can not recommend any particular company or publication. We only provide the information related to government document including the Pharmaceutical Affairs Law, announcements and notifications issued from MHLW. There are some publications of Japanese regulations and books for licensing procedures which are translated into English. So please contact the publishers directly and/or use some internet book search services to seek your information.

Q3 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 links page including Japan's pharmaceutical and medical device manufactures association which Japanese Marketing Authorization holders belong to at http://www.pmda.go.jp/link.html.

Q4 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.

Q5 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 at: http://www.mhlw.go.jp/index.html