GMP

MHLW/PMDA globalization efforts

News

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

• GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers

 

Documents for application of GMP inspection

• Submission Documents for Application of Drug Compliance Inspection
• Attachment, Form and Checklist
   

Guideline on Management of Computerized Systems

• Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs (Effective on October 21, 2010)
• Q & A

 

Guidance on the Manufacture of Sterile Pharmaceutical Products

• Guidance on the Manufacture of Sterile Pharmaceutical Products by Aseptic Processing (When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic.)

 

Regulations

• GQP Ministerial Ordinance (Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices)
• GMP Ministerial Ordinance (Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs)
• Regulations of Buildings and Facilities of Pharmacies, etc.
• Administrative Notice on Application of PICs GMP Guide
• Administrative Notice on Application of PICs GMP Guide (Q and A)

 

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.

• PDF
• word

Others

• Flow of Complaints Handling
• Information for manufacturers of pharmaceuticals for export from Japan.

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.