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