Skip Navigation

This Article
Right arrow Full Text Freely available
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (5)
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Fujiwara, Y
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Fujiwara, Y
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Japanese Journal of Clinical Oncology Pages 653-656

MD Reviewers' Role in the New Anticancer Drug Approval Process in the Newly Established Japanese Regulatory Agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center)
Reform of Japanese NDA Review System
NDA Approval Process in Japan
Roles of MD Reviewer
Perspective on Anticancer Drug Approval Process
   1. Approval requirements
   2. Off-label Usage
   3. Oral Anticancer Drugs
   4. Non-cytotoxic Anticancer Drugs
Proposal to Clinicians
References
MD Reviewers' Role in the New Anticancer Drug Approval Process in the Newly Established Japanese Regulatory Agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center)

MD Reviewers' Role in the New Anticancer Drug Approval Process in the Newly Established Japanese Regulatory Agency, PMDEC (Pharmaceuticals and Medical Devices Evaluation Center)

Yasuhiro Fujiwara

Evaluation Division I, Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences, Ministry of Health and Welfare, Tokyo, Japan

Reform of Japanese NDA Review System

The Japanese Ministry of Health and Welfare (MHW) has amended the Pharmaceutical Affairs Law and related laws and is reforming its New Drug Application (NDA) review system on the basis of the report by the . . . [Full Text of this Article]

NDA Approval Process in Japan

Roles of MD Reviewer

Perspective on Anticancer Drug Approval Process

1. Approval requirements

2. Off-label Usage

3. Oral Anticancer Drugs

4. Non-cytotoxic Anticancer Drugs

Proposal to Clinicians

References


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Jpn J Clin OncolHome page
K. Yamaguchi
Overview of Cancer Control Programs in Japan
Jpn. J. Clin. Oncol., February 1, 2002; 32(90001): S22 - 31.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
Y. Fujiwara
Current Status of Oral Anticancer Drugs in Japan
J. Clin. Oncol., October 1, 1999; 17(10): 3362 - 3365.
[Full Text] [PDF]