Drug Administration Law of the People's Republic of China
date:May 18, 2015
utions shall respectively implement the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and Good Clinical Practice (GCP).
The GLP and GCP shall be formulated by the department designated by the State Council.
Article 31 Production of a new drug or a drug admitted by national drug standards shall be subject to approval by the drug regulatory department under the State Council, and a drug approval number shall be issued for it, which the exception of the
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