Drugs
- Cancellation of items registered in Drug Master Files: PFSB/ELD Notification No.0208001, dated February 8, 2006 (PDF)
- Re: Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs”§ PFSB/ELD”¦SD””Notice, dated September 7, 2009 (PDF)
- Basic Principles on Global Clinical Trials : PFSB/ELD Notification No.0928010 dated September 28, 2007 (PDF)
- Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs:
PFSB/ELD Notification No. 1024002 dated October 24, 2005 (PDF)
- Guideline on Utilization of Master File for Drug Substances, etc. PFSB / ELD Notification No. 0210004 February 10, 2005 (PDF)
- Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. under the Revised Pharmaceutical Affairs Law: PFSB / ELD Notification No.0210001 dated February 10, 2005 (PDF)
- Handling of Applications for GMP Conformity Audit: PFSB/ELD Notification No. 0330006, PFSB/CND Notification No. 0330005, dated March 30, 2005 (PDF)
Medical Devices
- Q&A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries: Administrative Notice, dated June 23, 2006 (PDF)
- Handling of clinical study data on medical devices which was carried out in foreign countries: PFSB / MDE Notification No. 0331006, dated March 31, 2006 (PDF)
- Handling of the data of clinical studies for medical devices conducted in foreign countries: PAB / MHW Notification No. 479, dated March 31, 1997 (PDF)
- Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices:PMSB/ELD Notification No.0213001, dated February 13, 2003 (PDF)
- Applications for Marketing Approval for Medical Devices: PFSB Notification No. 0216002, dated February 16, 2005 (PDF)
- Handbook for Preparation of Summary Technical Documentation Submitted in Applications for Marketing Approval for Medical Devices: PFSB/ELD/OMDE Notification No. 0216003, dated February 16, 2005 (PDF)
- Handling of Applications for GMP Conformity Audit: PFSB/ELD Notification No. 0330006, PFSB/CND Notification No. 0330005, dated March 30, 2005 (PDF)
