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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15<br />
CDE<br />
� Highly professi<strong>on</strong>al team<br />
� focus <strong>on</strong> drug evaluati<strong>on</strong>, while also <strong>in</strong>volved<br />
with drug cl<strong>in</strong>ical trial regulatory system<br />
� Take the lead <strong>in</strong> <strong>in</strong>troduc<strong>in</strong>g <strong>in</strong>ternati<strong>on</strong>al<br />
evaluati<strong>on</strong> system <str<strong>on</strong>g>and</str<strong>on</strong>g> c<strong>on</strong>cepts<br />
� Heavy workload, lack of human resources<br />
� st<str<strong>on</strong>g>and</str<strong>on</strong>g>ardized, <strong>in</strong>dependent, science-based <str<strong>on</strong>g>and</str<strong>on</strong>g><br />
transparent<br />
� Active <strong>in</strong> <strong>in</strong>ternati<strong>on</strong>al activities, e.g. dialogue<br />
with US FDA, EMA<br />
STATE FOOD AND DRUG ADMINISTRATION
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