The Provisions specify that the application and approval of import crude drugs refer to a process in which SFDA, in accordance with the applications of applicants and legal procedures and requirements, conducts technical assessments and administrative examinations of crude drugs that are produced overseas and planned to be sold or used in China and then decide whether to approve the imports of the crude drugs. The applicants of crude drug imports should be drug manufacturing enterprises or distributing enterprises that have obtained Drug Manufacturing Certificate or Drug Supply Certificate in China.

The Provisions also stipulate that SFDA is responsible for the examination and approval of import crude drugs and supervising and managing registration, record keeping, port inspection and other work. The (food and) drug administrations of provinces, autonomous regions and municipalities supervise and manage import crude drugs in accordance with laws. The (food and) drug administrations at ports where drug imports are allowed or frontier ports where crude drug imports are allowed are responsible for registration and record keeping of import crude drugs and organizing and supervising port inspections. National Institute for the Control of Pharmaceutical and Biological Products is responsible for sample testing and validation & verification of quality standards of first-time import crude drugs. SFDA-designated drug testing institutions are responsible for port inspections of import crude drugs.

The Provisions require that crude drugs must be import via ports where drug imports are allowed or frontier ports where crude drug imports are allowed and for the frontier ports, only the crude drugs produced in countries or regions near the frontier ports could be imported.