Discuss on Supervision Mechanism for Online Drug Sales from the Perspective of Regulatory Science / 中国药房

ABSTRACT

OBJECTIVE：To provide su ggestions for perfecting drug electronic commerce regulatory policy and online drug sale supervision mechanism in China. METHODS ：The evolution of online drug sale policy in China were sorted out. The related regulations of online drug sale supervision mechanism stated in newly revised Drug Administration Law in 2019 and Measures for Online Drug Sale Supervision （Exposure Draft ）in Nov. 2020（hereinafter referred to as New Exposure Draft ）were analyzed on the basis of regulatory science to put forward the opinion. RESULTS & CONCLUSIONS ：Drug e-commerce in China has experienced 4 stages of development ，and is now in a new stage of encouraging innovation ，inclusiveness and prudence. The newly revised Drug Administration Law and New Exposure Draft catch up with the trend of “Internet plus ”development in the new era ，and conditionally liberate the network prescription drug operation ，and build new advantages and new kinetic energy for the development of pharmaceutical business. The new network drug supervision mechanism is an important embodiment of the regulatory department ’s active adaptation to social development ，a specific practice of the innovation of scientific drug regulatory concept，and also provides legal guarantee and policy space for new business forms of innovation drug circulation. However ，the author thinks that the relationship between prescription drug information and drug advertising ，network prescription transmission and authenticity ，legitimacy audit ，as well as the concept definition of sales behavior and service behavior are still questionable. Relevant concepts and terms should be adjusted and redefined. It is suggested that online drug sellers should be defined as “drug e-commerce operators ”or“online drug operators ”. The third party platform of online drug trading is defined as “drug e-commerce platform operator ”or“online drug trading platform operator ”.