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MHLW/PMDA globalization efforts


Date Title
October 30, 2020 GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
July 13, 2018 SMF(Site Master File) template
September 19, 2017 Confirmation, etc. of the status of pre-approval GMP compliance inspection for new drugs
Attachment 1
September 15, 2017 Submission Documents for Application of Drug Compliance Inspection
Attachment, Form and Checklist
July 17, 2013 New Application Procedure for GMP Certification between the European Union and Japan


News, press release announced by the Ministry of Health, Labour and Welfare (MHLW)

Date Title
June 6, 2013 Press Release: Exemption of the EU's regulatory control applicable to APIs exported from Japan to the European Union

 Background information


 Related information:
 The Official Journal of the European Union dated 4 June 2013 (PDF)

  Japanese version of the press release


Overview Guidance of GMP Compliance Inspection for Foreign Manufacturers


Documents for application of GMP inspection

Guideline on Management of Computerized Systems


Guidance on the Manufacture of Sterile Pharmaceutical Products




SMF(Site Master File) template

 This SMF template was discussed at APAC (Asia Partnership Conference of Pharmaceutical Associations) meeting with Asian regulatory authority such as Indonesia, South Korea, Taiwan and Thailand and we reached conclusion to promote usage of this template. This is a reference to the manufacturing sites to prepare the SMF. Whenever you apply this SMF template to your manufacturing sites, please modify this to the present condition of the your sites.


Legal authorities of GMP inspections in Japan (English)

Please use this material for explaining legal authorities of GMP inspections in Japan to foreign companies, etc.

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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