On April 24, the O’Neill Institute hosted a presentation by two visiting scholars from the Shanghai Food and Drug Administration (SHFDA). Mr. Ji Chen is the Deputy Director of the Department of Drug Sale and Marketing Control at the SHFDA headquarters. Mr. Junhua Wu is the Senior Drug Inspection Officer of the Pudong Branch of the SHFDA.
Together they led a presentation and discussion on drug sale management in China. The first half of the presentation discussed drug distribution administration in China, including the general situation about drug administration, the organization structure of CFDA (China Food and Drug Administration), responsibilities of CFDA, the business environment for drug distribution companies in China, and existing problems in the regulatory process of drug distribution. Mr. Chen analyzed that the excessive number of drug distribution companies is a contributing factor to a lengthy supply chain, increasing drug prices as well as counterfeit and substandard drugs. However, reducing the redundant companies is hard in China because they are important tax sources and job creators for the local economy. To solve these issues, China is encouraging mergers and acquisitions within the drug distribution industry and increasing legal enforcement. Mr. Wu introduced regulations related to pharmacies, development of online drug sale, and supervision in China in the second half of the presentation. In addition, he compared differences between China and the U.S. including pharmacy service and administration. The presenters answered the audience’s questions about definitions of counterfeit and substandard drugs in Chinese law and responsibilities of corresponding offices regulating drug sales.
Mr. Chen and Mr. Wu are two visiting scholars under the blue bird visiting scholar program that demonstrates the strong partnership between the O’Neill Institute and the Shanghai FDA. Since Fall 2011, the O’Neill Institute has hosted eight officials for detailed comparative research on drug and medical device safety issues. In Fall 2013, O’Neill Institute will host another two SHFDA officials to conduct research on food safety.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.