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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� Differences<br />
1.cl<strong>in</strong>ical trial of new drug shall be approved <strong>in</strong> written form by drug regulatory<br />
authorities<br />
2、<strong>Trials</strong> must be d<strong>on</strong>e <strong>in</strong> <strong>in</strong>stitutes accredited by SFDA<br />
3、A s<strong>in</strong>gle department <strong>in</strong> a drug cl<strong>in</strong>ical trial <strong>in</strong>stitute cannot c<strong>on</strong>duct trials <strong>on</strong> the<br />
same drug from different sp<strong>on</strong>sors , <str<strong>on</strong>g>and</str<strong>on</strong>g> shall not c<strong>on</strong>duct too many studies<br />
4、ethics committee is subord<strong>in</strong>ated to medical <strong>in</strong>stitutes.<br />
34<br />
STATE FOOD AND DRUG ADMINISTRATION
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