Basic Principles on Global Clinical Trials (Reference cases) posted

 

 The following English translations of Japanese notifications and administrative notices are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail.

Drugs

Issue Date

Document Type & No.

Title

Subject

Sep. 6, 2012

PFSB/ELD
Administrative
Notice
Basic Principles on Global Clinical Trials (Reference Cases) (PDF) Clinical trials

Apr. 18, 2012

PFSB/ELD
Administrative
Notice
English Translations of the Guidance for Establishing Safety in First-in-Human Studies during Drug Development and its Questions and Answers (PDF) Clinical trials

Mar. 30, 2012

PFSB/ELD
Administrative
Notice
On the Standard Review Timeline for New Drug Applications (PDF) Regulatory submission

Jan. 17, 2011

PFSB/ELD
Administrative
Notice
Format for Preparing the Common Technical Document for Submission of New Drug Applications to Reduce Total Review Time (PDF) Regulatory submission

July 9, 2010

PFSB/ELD Notification No. 0709-1 On Release of the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents (PDF) Clinical trials

July 9, 2010

PFSB/ELD Administrative Notice On Release of Questions and Answers (Q&As) regarding the Guideline for Clinical Evaluation of Oral Hypoglycemic Agents (PDF) Clinical trials

June 9, 2010

PFSB/ELD-CND
Administrative
Notice
Points to Consider for Reducing Total Review Time for New Drug Applications (PDF) Regulatory submission

Sep. 7, 2009

PFSB/ELD-SD Administrative Notice Q & A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs (PDF) Post-marketing safety

June 13, 2008

PFSB Notification No. 0613007 Guidance on the Implementation of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs as Revised by the Ministerial Ordinance for the Partial Revision of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Drugs (PDF) GLP

Sep. 28, 2007

PFSB/ELD Notification No. 0928010 Basic Principles on Global Clinical Trials (PDF) Clinical trials

Feb. 8, 2006

PFSB/ELD Notification No. 0208001 Cancellation of items registered in Drug Master Files (PDF) DMF

Oct. 24, 2005

PFSB/ELD Notification No. 1024002 Documents to Be Attached to Applications for Accreditation of Foreign Manufacturers of Drugs and Quasi-Drugs (PDF) Accreditation of foreign manufacturers

Mar. 30, 2005

PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005
Handling of Applications for GMP Inspections (PDF) GMP

Feb. 10, 2005

PFSB/ELD Notification No. 0210001 Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. under the Revised Pharmaceutical Affairs Law (PDF) Regulatory submission

Feb. 10, 2005

PFSB/ELD Notification No. 0210004 Guideline on Utilization of Master File for Drug Substances, etc. (PDF) DMF

Medical Devices

Issue Date

Document Type & No.

Title

Subject

Feb. 6, 2009

PMDA Notification No. 0206007 Procedures for Public Release of Information on Review of Applications for New Medical Devices (PDF) Public release of information

June 13, 2008

PFSB Notification No. 0613010 Guidance on the Implementation of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices as Revised by the Ministerial Ordinance for the Partial Revision of the Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices (PDF) GLP

June 23, 2006

PFSB/ELD/
OMDE Administrative Notice
Q & A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries (PDF) Regulatory submission

Mar. 31, 2006

PFSB/MDE Notification No. 0331006 Handling of clinical study data on medical devices which was carried out in foreign countries (PDF) Regulatory submission

Mar. 30, 2005

PFSB/ELD Notification No. 0330006
PFSB/CND Notification No. 0330005
Handling of Applications for GMP Inspections (PDF) GMP (QMS)

Feb. 16, 2005

PFSB/ELD/
OMDE Notification No. 0216003
Handbook for Preparation of Summary Technical Documentation Submitted in Applications for Marketing Approval for Medical Devices (PDF) Regulatory submission

Feb. 16, 2005

PFSB Notification No. 0216002 Applications for Marketing Approval for Medical Devices (PDF) Regulatory submission

Feb. 16, 2005

PFSB/ELD/
OMDE Notification No. 0216001
Points to Consider When Applying for Marketing Approval for Medical Devices (PDF) Regulatory submission

Feb. 13, 2003

PMSB/ELD Notification No. 0213001 Basic Principles of Biological Safety Evaluation Required for Application for Approval to Manufacture (Import) Medical Devices (PDF) Regulatory submission

Mar. 31, 1997

PAB/MHW Notification No. 479 Handling of the data of clinical studies for medical devices conducted in foreign countries (PDF) Regulatory submission

Pharmaceuticals and Medical Devices Agency

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

 

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