Legal basis: Article 32 of the Drug Administration Law of the People's Republic of China * * * * The holder of the drug marketing license may produce the drug by himself or entrust the drug production enterprise to produce it.
If the holder of the drug marketing license produces drugs on his own, he shall obtain a drug production license in accordance with the provisions of this law; Where production is entrusted, qualified pharmaceutical production enterprises shall be entrusted. The holder of the drug marketing license and the entrusted production enterprise shall sign an entrustment agreement and a quality agreement, and strictly fulfill the obligations stipulated in the agreement.
The drug supervision and administration department of the State Council shall formulate guidelines for the quality agreement of drug consigned production, and guide and supervise the holders of drug marketing licenses and consigned production enterprises to fulfill their obligations of drug quality assurance.
Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use and pharmaceutical precursor chemicals shall not be commissioned for production; However, unless otherwise provided by the drug supervision and administration department of the State Council.