Pursuant to the provisions of Article 2, Paragraph 12 of the Pharmaceutical Affairs Law (Law No. 145, 1960, hereinafter referred to as “Revised Pharmaceutical Affairs Law”) as amended by the enforcement of the Law for Partial Revision of the Pharmaceutical Affairs Law and the Blood Collection and Donation Services Control Law (Law No. 96, 2002), pharmaceuticals as drug substances shall not require marketing approvals. Full document...

and maintain the document defining the product specifications and QMS requirements (Seihin Hyojun Sho), or identifying Seihin Hyojun Sho(QMS Ordinance Article 6 Para 2). Full document...

The following guideline on the utilization of the MF system published so that you could inform relevant businees and organization under your jurisdiction of the guideline for their sake of submitting application for MF registration,etc. Full document...

This paper describes basic principles for global clinical trials including Japan and will promote further consideration by sponsors as well as active participation for Japan in global clinical trials. Full document...

This paper describes basic principles for global clinical trials including Japan and will promote further consideration by sponsors as well as active participation for Japan in global clinical trials. Full document...

Explanation Application for Accreditation of Foreign Manufacturers. Full document...

The documents to be attached to applications for accreditation of foreign manufacturers have been set out in the Notification of Director-General, Pharmaceutical and Food Safety Bureau, MHLW: “Enforcement of the Law for Partial Revision of the Pharmaceutical Affairs Law and Blood Collection and Donation Services Control Law, etc.” Full document...