Clinical research strategies for imported drugs registration
10.3969/j.issn.1001-6821.2009.04.023
- VernacularTitle:进口药品注册临床试验的整体策略
- Author:
Cai-Lian KANG
1
;
Chen-Yan GAO
Author Information
1. 国家食品药品监督管理局药品审评中心
- Keywords:
ICHE5;
imported drugs registration
- From:
The Chinese Journal of Clinical Pharmacology
2009;25(4):375-379
- CountryChina
- Language:Chinese
-
Abstract:
The clinical trial requirements for imported drug are under seri-ous discussion. This article gives the answers for the following questions:are the clinical trials absolute necessary if the drugs want to launch on China's market? How to conduct clinical trials to fulfill the regulation re-quirements? Base on ICHE5 guideline, the amount and content of clini-cal trials depend on the "demand". The key point considered to the "de-mand" is the difference of ethnic and clinical practice, which lies on two important aspects: the disease being treated and molecular characters.Invesitegators should analysis the pharmaeokinetic and pharmakcoinetic/pharmacodynamic characters in different ethnics. And invesitegators should also analysis the clinical practice difference on efficacy and safe-ty. Aim at these difference, the investigators design the corresponding clinical trials. This article will give suggestions to the post-marketing clin-ical trials and global multi-national clinical trials too.
