Optimizing Drug Registration in China: Category I …

WHITE | April 2013 Optimizing drug Registration in China: Category I RouteOPTIMIZING drug Registration IN CHINA: Category I route 2 EXECUTIVE SUMMARYWith a population of billion and a pharmaceutical market growing at nearly 20 percent per year, China offers both huge opportunities and challenges for drug developers seeking to optimize development and product Registration timelines. Multinational pharmaceutical companies are conducting more clinical trials in China as part of their international multicenter development programs. Chinese data from global multicenter studies now support the most common route to product Registration in China the Category III route , an application for an import drug , the Category III route to Registration may not be the optimal pathway to the Chinese market for pharmaceutical products, in light of year-long review times required for clinical trial applications and the timing of subsequent marketing application submission and approval.

OPTIMIING DRUG REGISTRATION IN CHINA: CATEGORY I ROUTE 6 Category I New Drug Application Given the limitations of the category III IDL route, some developers are exploring the alternative—pursu-

Tags:

  Applications, Route, Drug, Chain, Optimizing drug registration in china, Optimizing, Registration, Category, Drug registration in china, Drug application

Information

Related search queries