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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Generics<br />
� Adhere to “strict c<strong>on</strong>trol over both entrance <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
exit”<br />
� Clarify resp<strong>on</strong>sibilities, risk-c<strong>on</strong>trol measures <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
obligati<strong>on</strong>s of all participants <strong>in</strong> the trials<br />
� Provide detailed guidel<strong>in</strong>es for evaluati<strong>on</strong> <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
approval of cl<strong>in</strong>ical trials for generics<br />
38<br />
STATE FOOD AND DRUG ADMINISTRATION