The Drug Administration Law was promulgated in 1984, and amended in 2001, 2013, 2015 and 2019 respectively. The latest revision entered into force on December 1, 2019.

There are 155 articles in total.

The key points are as follows:

1.This Law shall apply to drug research and development, manufacturing, business operation and use in the People’s Republic of China and the supervision and administration activities thereof.(Article 2)

2.The competent drug administrative department of the State Council shall be in charge of drug supervision and administration work nationwide.(Article 8)

3.Drug marketed in China shall be approved by the medical products administration under the State Council and be with a drug registration certificate, except Chinese medicinal materials and Chinese medicinal herb slices not under approval administration.(Article 24)

4.The “Pharmacopoeia of the People’s Republic of China” and drug standards published by the drug administrative department of the State Council shall be the national drug standards.(Article 28)

5.Newly-discovered and overseas-introduced herbs may be sold only upon approval by the drug administrative department of the State Council.(Article 63)

6.Drugs shall be imported from approved drug -importing ports, and the drug -importing enterprise shall file record with the drug administrative authorities at the locality of the port.(Article 64)

7.Importers and exporters of anesthesia and psychiatric drugs within the scope stipulated by the State shall present the importation permit or exportation permit issued by the drug administrative department of the State Council.(Article 66)