Industry leading quality systems
and world-class regulatory expertise

MHLW

Ministry of Health, Labour and Welfare

The Ministry of Health, Labour and Welfare has responsibilities for approval and administration of drugs, medical devices and cosmetics in Japan.

Technical and scientific support for ICH activities are provided by the Pharmaceuticals and Medical Devices Agency (PMDA) (which was established in April 2004 as a new administrative agency for scientific review for drug approval), and by the National Institute of Health Sciences (NIHS) and other experts from academia.

This page provides access to regulatory guidance and other resources that are generally available from web sites operated and maintained by PMDA.

Documents that are available from MHLW> PMDA> ICH in Japanese can be found here at: http://www.pmda.go.jp/ich/ich_index.html

Have a question? Click here to contact us.

Title		Type	Posted
	Quality Guidelines	Draft Guidance	December 2009
View Link
	Safety (non-clinical) Guidelines	Guideline	December 2009
View Link
	Gene Therapy Guidelines	Guideline	December 2009
View Link
	Announcement for the public comments for ICH Considerations for “General Principles to Address Virus and Vector Shedding”	Guideline	December 2009
View Link
	Pharmaceuticals and Medical Devices Agency, Japan	Guideline	December 2009
View Link

* Denotes a required field

* First Name * Last Name * Company Name * Email * State/Region * Country * Zip/Postal Code  

IMPORTANT NOTICE The links on this page are provided for the sole purpose of assisting visitors to locate the relevant web sites and BioReliance does not make any warranty with respect to the accuracy of the documents available from these sites. All documents are the copyright of the respective site owners and may be subject to certain conditions of use. Although care has been taken in the preparation of this web site BioReliance cannot be held responsible for the accuracy of the information contained within the web site, nor for any consequence arising from such information. You are advised to seek additional advice when making decisions based on information you have obtained from this web site.