Off-Label Prescription and How it is (Not) Regulated in China


  • Vera Lúcia C. Raposo


Off-label prescription—the use of a drug outside the scope of its marketing authorization (MA) and the content of its summary of product characteristics (SmPC)—is a medical practice spread all around the world, China being no exception. Several reasons, mostly related to financial strategies from pharmaceutical companies, can justify the decision of not requiring an MA for a certain drug use. The main reason is the purpose of having a profit without taking excessive risks, either economic or legal. This paper will define off-label prescription, discuss the various reasons leading to it, describe the general framework of this practice in Europe and in the United States and analyze off-label prescription in China, describe its regulation (actually, the lack of it) in the Chinese legal system and comment on the actual practice by Chinese health care providers. To conclude, the paper will sustain that a regulation for off-label prescription is essential to clarify for doctors the requirements of lawful off-label uses, and thus protect patients from injuries resulting from risky of-label prescriptions.

Author Biography

Vera Lúcia C. Raposo

Professor, Faculty of Law of Macau University, China and the Faculty of Law of Coimbra University