| Date |
Title |
March 30, 2018
December 27, 2017
(Originally Posted in Japanese) |
Switching of Small-bore Connectors for Neuraxial Anesthesia |
March 30, 2018
October 4, 2017
(Originally Posted in Japanese) |
Introduction of the International Standards (ISO (IEC) 80369 series) Related to Connectors for Prevention of Interconnection |
February 8, 2017
October 31, 2014
(Originally Posted in Japanese) |
Points to Consider for Consultations Related to Revisions of Package Insert Language |
February 8, 2017
October 31, 2014
(Originally Posted in Japanese) |
Points to Consider regarding the Notification and Publication of Package Insert Language |
February 1, 2017
December 27, 2016
(Originally Posted in Japanese) |
Notification: "Handling of Powdered Medical Gloves" |
October 26, 2016
October 2, 2014
(Originally Posted in Japanese) |
Administrative Notice: Reports of Adverse Drug Reactions, etc. of Pharmaceuticals
Attachment: Reports of Adverse Drug Reactions, etc. of Pharmaceuticals |
July 29, 2016
November 25, 2014
(Originally Posted in Japanese) |
Administrative Notice: Notice concerning Revisions to the "Standard Workflow for the Revision of Drug Product Package Inserts"
Reference material: Standard Workflow for the Revision of Drug Product Package Inserts |
May 20, 2016
September 28, 2015
(Originally Posted in Japanese) |
Administrative Notice
Q&A on Post-marketing Reports on Adverse Drug Reactions, etc.
and Clinical Trial Reports on Adverse Drug Reactions, etc Conforming to Implementation Guide of E2B (R3) |
January 8, 2016
March 24, 2006
(Originally Posted in Japanese) |
Implementation Methods, etc. of Early Post-marketing Phase Vigilance for Prescription Drugs
Q&A on Early Post-marketing Phase Vigilance for Prescription Drugs |
| December 17, 2014 |
Q&A on Adverse Drug Reaction and Malfunction Reports of Combination Products |
| December 5, 2014 |
Handling of Marketing Application for Combination Products |
| November 20, 2014 |
Guideline on Revision of Precautions and other information |
| January 31, 2014 |
Good Vigilance Practice Ordinance to be complied by Marketing Authorization Holders |
| October 26, 2009 |
Re: Q&A on use-results surveys conducted as All-Case Surveillance and Early Post-Marketing Phase Vigilance (EPPV) for Prescription Drugs |
