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GMP

MHLW/PMDA globalization efforts

News
Date Title
June 18, 2015 Documents to be submitted to PMDA when applying for its pre-approval GMP inspection or periodic post-approval  inspection of drugs or quasi-drugs (PDF)
[Form1] (MS-WORD)
[Form3] (MS-WORD)
[Attachment3](MS-WORD)
[Attachment4](MS-WORD)
July 17, 2013 New Application Procedure for GMP Certification between the European Union and Japan (PDF)

 

 

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 (PDF)

 Background information (PDF)

 

 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

 

Regulations

 

Others

JCN 3010005007409

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

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