China's food and drug regulatory system has ushered in the fifth major change in 20 years. According to the State Council's institutional reform plan announced on March 13, the former State Food and Drug Administration will no longer retain, and the State Drug Administration will be established separately, and will be managed by the newly formed "three-in-one" National Market Supervision Administration.

The State Administration of Market Supervision has integrated the duties of the State Administration for Industry and Commerce, the duties of the General Administration of Quality Supervision, Inspection and Quarantine, the duties of the State Food and Drug Administration, and the duties of the State Development and Reform Commission for price supervision and inspection and anti-monopoly law enforcement. The operators concentrated on anti-monopoly law enforcement and the Office of the State Council Anti-monopoly Committee.

The changes of the new State Drug Administration are mainly reflected in three aspects: First, the word "food" has been removed; second, the word "total" has been removed, and it is no longer directly under the State Council; third, the drug regulatory agency is only set at the provincial level. .

In an interview with the media, Hu Yinglian, an expert member of the China Drug Administration Research Association and an associate professor of the National School of Administration, summarized the reform plan as "a big market and specialized drugs" and seized the two key points of current food safety management, namely food safety supervision. Coordination and comprehensiveness, the particularity and professionalism of drug regulation.

Hu Yinglian believes that in the horizontal dimension, the establishment of the State Drug Administration alone can strengthen professional law enforcement while emphasizing professional matters by professional people.

In the vertical dimension, the drug supervision institution is only set at the provincial level, with the significance of a certain vertical management, to solve the problem of "power and responsibility isomorphism".

In fact, after the large integration of the national food and drug regulatory agencies in 2013, many places did not separately set up food and drug regulatory agencies with reference to the State Council model, but instead established a system of integration of industry and commerce, quality supervision, food and medicine, and established new market supervision and management. Bureau. Zhejiang, Anhui and other places are the first testers of this model.

According to the data of the State Administration for Industry and Commerce in February 2017, about one-third of the sub-provincial cities, one-fourth prefecture-level cities, and two-thirds of the counties in the country have implemented comprehensive market supervision.

In order to see more clearly the changes in China's food and drug regulatory system along with social development, we may wish to review the five major institutional reforms in the past 20 years.

(a) In 1998, the State Drug Administration (SDA): the new independent regulatory authority

In 1978, the State Pharmaceutical Administration was established.

In 1998, the State Drug Administration was established, directly under the State Council, and is the administrative law enforcement agency of the State Council in charge of drug supervision.

(b) In 2003, the State Food and Drug Administration (SFDA): increased food regulation

In March 2003, the State Food and Drug Administration was established on the basis of the State Drug Administration, and it is still directly affiliated to the State Council. Its main responsibilities are: to continue to exercise the functions of the State Drug Administration, and to be responsible for the comprehensive supervision and organization and coordination of the safety management of food, health products and cosmetics, and to organize the investigation and handling of major accidents according to law.

(3) In 2008, the State Food and Drug Administration (SFDA): administered by the Ministry of Health

In March 2008, the name of the State Food and Drug Administration (SFDA) remained unchanged and was placed under the management of the former Ministry of Health as its direct agency. Director Shao Mingli also serves as the deputy minister of the Ministry of Health.

In 2012, the former Deputy Minister of Health Yin Li was also the Director of the State Food and Drug Administration.

(IV) In 2013, the State Food and Drug Administration (CFDA): Independent and large-scale integration, ending "Jiulong Water Control"

In March 2013, the State Food and Drug Administration was listed and no longer managed by the Ministry of Health. It is the direct authority of the State Council to comprehensively supervise the management of pharmaceuticals, medical devices, cosmetics, health foods and food safety. The English abbreviation is "SFDA". Becomes "CDFA". Yin Li served as deputy director, and Zhang Yong, former director of the Food Safety Office of the State Council, became the director.

CFDA integrates the duties of the Food Safety Office, the duties of the Food and Drug Administration, the food safety supervision and management duties of the AQSIQ production department, and the food safety supervision and management duties of the circulation of the State Administration for Industry and Commerce, and the food safety in the past "The situation is over.

In 2015, the former Deputy Secretary of the State Council Bi Jingquan became the director of the State Food and Drug Administration.

(5) In 2018, the State Drug Administration: "big market, specialty drugs"

In March 2018, the State Council's institutional reform program will assume the duties of the State Administration for Industry and Commerce, the duties of the General Administration of Quality Supervision, Inspection and Quarantine, the duties of the State Food and Drug Administration, and the price supervision and inspection and anti-monopoly enforcement duties of the National Development and Reform Commission. The operators of the Ministry of Commerce concentrated on anti-monopoly law enforcement and the Office of the Anti-monopoly Committee of the State Council and other responsibilities, and established the State Administration of Market Supervision as a direct agency of the State Council.

Taking into account the particularity of drug supervision, the State Drug Administration has been established separately and is administered by the State Administration of Market Supervision. The market supervision is subject to hierarchical management. The drug regulatory agency is only set at the provincial level, and the supervision of drug sales and sales is uniformly undertaken by the municipal and county market supervision departments.