Regulation and Views on Drug Clinical Trials in China - Apec-ahc.org
Regulation and Views on Drug Clinical Trials in China - Apec-ahc.org
Regulation and Views on Drug Clinical Trials in China - Apec-ahc.org
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1. improve legal <str<strong>on</strong>g>and</str<strong>on</strong>g> regulatory systems<br />
2. science-based selecti<strong>on</strong> of reference drug <strong>in</strong> cl<strong>in</strong>ical<br />
trials<br />
3. coord<strong>in</strong>ati<strong>on</strong> between DRA <str<strong>on</strong>g>and</str<strong>on</strong>g> EC<br />
4.re<strong>in</strong>force process c<strong>on</strong>trol over cl<strong>in</strong>ical trials (SAE<br />
m<strong>on</strong>itor<strong>in</strong>g, risk-c<strong>on</strong>trol plan, site <strong>in</strong>specti<strong>on</strong>,<br />
enforcement)<br />
5.c<strong>on</strong>sistent quality of drug cl<strong>in</strong>ical trials<br />
6.compensati<strong>on</strong> for damages to the subjects<br />
37<br />
STATE FOOD AND DRUG ADMINISTRATION
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