This regulation is formulated in accordance with the "Pharmaceutical Administration Law of the People's Republic of China", the "Vaccine Administration Law of the People's Republic of China" and relevant laws and regulations. The aim is to strengthen the supervision and management of overseas drug marketing authorization holders, implement the main responsibility for post-marketing quality management of drugs, and standardize the activities of overseas drug marketing authorization holders designating domestic responsible persons.

The overseas holder refers to the overseas drug marketing authorization holder who has obtained the drug registration certificate issued by the National Medical Products Administration. The domestic responsible person is designated by the overseas holder，and fulfill the obligations of a marketing authorization holder for drugs. Domestic enterprise legal persons that bear joint and several liability with the marketing authorization holder of the drug.

The overseas holder shall report to the drug regulatory department the designated domestic responsible person before the first import and sale of the drug, and upload the authorization materials of the designated domestic responsible person.

For a single drug variety marketed within the territory of China, the overseas holder shall appoint a sole domestic responsible person within China for it to fulfill the obligations of the drug marketing authorization holder. The same domestic responsible person within China may accept the designation of different overseas holders and different imported drug varieties.

The name, address and contact information of the domestic responsible person shall be listed in the drug instructions.