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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

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