the chinese regulatory licensing regime for pharmaceutical products

422 Michigan Telecommunications and Technology Law Review [Vol. 15:417
requirements, licensing is conditioned upon having appropriate staff,
facilities, and management systems. 29
Sixth, before making medicinal preparations for patients, a medical
organization must obtain prior approval from the Health Authority at the
provincial level, as well as a dispensing permit issued by a branch of the
SFDA at the same level. 30 To ensure quality, licensing is conditioned
upon the organization’s facilities, management systems, and sanitation,
as well as other requirements. 31
Seventh, drugs cannot be imported into China without a Registration
Certificate for Imported Drugs (“RCID”). 32 For a RCID to be issued,
prospective importers generally must satisfy the SFDA criteria for safety
and efficacy, but they may be exempt if the drug is for emergency hospital
use or individual use. 33 Additionally, before every importation, the
importer must obtain an imported drug customs clearance from an affiliate
of the SFDA at the port designated for their drugs to enter China. 34
The 2001 Drug Administration Law no longer imposes compulsory testing
on imported drugs unless they are entering China for the first time;
however, a pharmaceuticals testing institute appointed by an affiliate of
the SFDA will carry out selective testing on imported drugs after they
enter the Chinese market. 35
Eighth, three kinds of pharmaceuticals—namely bio-products stipulated
by the SFDA, drugs being sold for the first time in China, and other
drugs stipulated by the State Council—must pass tests conducted by appointed
institutes before being imported or marketed. 36 This compulsory
testing (“a test pass license”) is a de facto licensing requirement. 37
Lastly, no over-the-counter drug can be advertised in China unless
the sponsor obtains an advertising license from a branch of the SFDA at
the provincial level and an advertising permit from a branch of the State
Industry and Commerce Administration at the county level or above. 38
Only medicinal and pharmaceutical journals, jointly-authorized by the
Health Authority under the State Council and the SFDA, can carry ad-
29. Id. art. 15.
30. Id. art. 23.
31. Id. art. 24.
32. Id. art. 39.
33. Id.
34. Id. art. 40.
35. Id. arts. 40–41.
36. Id. art. 41.
37. Id.
38. See id. art. 60; Advertisement Law (promulgated by the Standing Comm. Nat’l
People’s Cong., Oct. 27, 1994, effective Feb. 1, 1995) art. 34 (P.R.C.).