spacer
home > epc > spring 2002 > clinical trials and new drug applications in japan
PUBLICATIONS
European Pharmaceutical Contractor

Clinical Trials and New Drug Applications in Japan

The Common Technical Document (CTD) is a major step towards internationally recognised marketing authorisation applications, but its success will be affected by processes at a national level. In Japan, a number of recent clinical, ethical, regulatory and review changes also serve to provide even better access to this important region.

There has been considerable change in the Japanese regulatory framework over the last five years or so, driven by external (ICH) and internal (government) factors. The result is more effective, transparent and manageable approval processes.

With a population of 125 million (1), a recent international agreement on the CTD, and significant inclusion of other ICH steps, Japan represents a sizeable and accessible marketplace for research and marketing - more than ever before. In the mid- to late nineties, in excess of 7,000 ethical, over-the-counter (OTC) and quasi-drug manufacturing licences were held in Japan (1,2). With that in mind, the essential steps to obtain approval for clinical trials and to obtain marketing authorisation are described below.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Tony Mitchell, Director of Regulatory Affairs at Origin Pharmaceutical Services Limited

Dr Tony Mitchell is Director of Regulatory Affairs and Strategic Services at Origin Pharmaceutical Services Limited.

He has considerable experience in the international registration of pharmaceutical products. He previously held regulatory positions at Fisons Pharmaceuticals, British Biotech Pharmaceuticals Limited and Pharmakopius, the international contract research organisation.

spacer
Dr Tony Mitchell
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Signant Health Appoints Lawrence Miller as Chief Technology Officer

LONDON & PHILADELPHIA – June 13, 2019: Signant Health, formerly CRF Bracket, has appointed Lawrence Miller as Chief Technology Officer. Signant unites electronic Clinical Outcomes Assessment (eCOA), eConsent, Patient Engagement, Interactive Response Technology (IRT), Clinical Supply Management and Endpoint Quality into the industry’s most comprehensive patient-centric suite of technology solutions and services. An accomplished innovator, Miller brings unique vision and expertise to a Signant team already committed to advancing clinical research with its next-generation technology portfolio.
More info >>

White Papers
 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement