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Regulatory Information

Notification

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

Others

Date Title
January 30, 2018 Link to Regulatory Notice ”Instruction of Package Insert for Prescription Drug” and ”Points to Consider for the Instruction of Package Insert for Prescription Drug” translated by industry associations (PhRMA and EFPIA)
January 9, 2015 Presentation material: package insert notification system

Frequently Asked Questions (FAQ)

JCN 3010005007409

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

Access/Map

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Regulatory Information
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