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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Inspecti<strong>on</strong>s<br />
� Supervisory <strong>in</strong>specti<strong>on</strong> <strong>on</strong> <strong>in</strong>stitutes<br />
Inspecti<strong>on</strong> for accreditati<strong>on</strong> <str<strong>on</strong>g>and</str<strong>on</strong>g> follow-up <strong>in</strong>specti<strong>on</strong>s(<br />
comprehensive <strong>in</strong>specti<strong>on</strong>s)<br />
� Validati<strong>on</strong> of cl<strong>in</strong>ical trials<br />
site-<strong>in</strong>specti<strong>on</strong> for drug cl<strong>in</strong>ical trial registrati<strong>on</strong>(regular <strong>in</strong>specti<strong>on</strong>)<br />
for-cause <strong>in</strong>specti<strong>on</strong> <strong>in</strong> evaluati<strong>on</strong>( for-cause <strong>in</strong>specti<strong>on</strong> )<br />
<strong>in</strong>specti<strong>on</strong> for potential n<strong>on</strong>-compliance( for-cause <strong>in</strong>specti<strong>on</strong> )<br />
35<br />
STATE FOOD AND DRUG ADMINISTRATION
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