Regulation and Views on Drug Clinical Trials in China - Apec-ahc.org

Drug Administration Law
� Article 29 The dossier on a new drug research <strong>and</strong> development
including the manufacturing process, quality specifications, results of
pharmacological <strong>and</strong> toxicological study, <strong>and</strong> the related data <strong>and</strong>
the samples shall, in accordance with the regulations of the drug
regulatory department under the State Council, be truthfully
submitted to the said department for approval, before clinical trial is
conducted. Measures for verifying the qualifications of clinical study
institutions for drugs shall be formulated jointly by the drug regulatory
department <strong>and</strong> the administrative department for health under the
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State Council.
� Article 30 The institutions for non-clinical safety evaluation <strong>and</strong> study
<strong>and</strong> clinical study institutions shall respectively implement the Good
Laboratory Practice for Non-Clinical Laboratory Studies (GLP) <strong>and</strong>
Good Clinical Practice (GCP).
The GLP <strong>and</strong> GCP shall be formulated by the department designated
by the State Council.
STATE FOOD AND DRUG ADMINISTRATION