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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Highlights of Ch<strong>in</strong>ese GCP<br />
� GCP implementati<strong>on</strong> is specified <strong>in</strong> Ch<strong>in</strong>ese legislati<strong>on</strong><br />
� Procedures <str<strong>on</strong>g>and</str<strong>on</strong>g> st<str<strong>on</strong>g>and</str<strong>on</strong>g>ards <strong>in</strong> place for medical <strong>in</strong>stitute<br />
accreditati<strong>on</strong><br />
� grow<strong>in</strong>g awareness of GCP implementati<strong>on</strong> am<strong>on</strong>g<br />
medical <strong>in</strong>stitutes, drug manufacturers <str<strong>on</strong>g>and</str<strong>on</strong>g> dug regulatory<br />
authorities at various levels; quality of trials be<strong>in</strong>g<br />
improved<br />
� <strong>in</strong>crease <strong>in</strong> MRCT<br />
� c<strong>on</strong>formity with <strong>in</strong>ternati<strong>on</strong>al GCP requirements<br />
32<br />
STATE FOOD AND DRUG ADMINISTRATION
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