According to the officially announced institutional reform plan, the State Council will set up the State Market Supervisory Administration. The duties of the State Administration for Industry and Commerce, the duties of the General Administration of Quality Supervision, Inspection and Quarantine, and the duties of the State Food and Drug Administration. . . . . . Such as the integration of duties, the establishment of the State Administration of Markets, as a direct agency of the State Council.
The "State Food and Drug Administration" was abolished. At the same time, taking into account the particularity of drug supervision, the State Drug Administration was established and administered by the State Administration of Market Supervision. The market supervision implements hierarchical management, and the drug regulatory agency is only set at the provincial level, which means that the existing municipal and county food and drug administrations will be completely cancelled and merged into the municipal and county drug market supervision departments.
The important thing is said three times, the three major changes in the core: 1. The State Food and Drug Administration has cancelled the word "food"; 2. The word "total" of the "General Administration" has been cancelled. The new State Drug Administration does not It is directly administered by the State Council, but is returned to the State Administration of Small Markets; The drug regulatory agency is only set at the provincial level, and the municipal and county food and drug administrations cancel and merge.
The history of the National Food and Drug Administration (CFDA) is not easy. It has been hard to fight for decades. After repeated attempts, it has broken away from the shackles of the Ministry of Health and gained independence. The good days are only five years (just one session). It has been included in the embrace of the State Administration of Markets, hehe!
Let's take a look at the history of CFDA's struggle:
The first stage: the newly born SDA (1998-2003)
Experts: In order to comply with the reform needs of medical and pharmaceutical separation, it is necessary to have an independent regulatory department to do a good job in drug supervision.
Leadership: Well, then set up a separate National Drug Administration (SDA).
1998: The State Pharmaceutical Administration under the former National Economic Commission merged with the Department of Medicine of the Ministry of Health and then absorbed some of the institutions of the State Administration of Traditional Chinese Medicine to establish the State Drug Administration (deputy ministerial level).
At this stage, the State Food and Drug Administration, as a new independent department, is like a young and daring teenager. It is full of enthusiasm and enthusiasm. It has developed rapidly in China, and the pharmaceutical industry has become more standardized (at least in form) and pharmaceutical GMP in China. Forcibly pushed open; drug registration is incorporated into the unified management of the country, and the era in which the provincial and municipal food and drug administrations can approve drugs is gone forever.
Second stage: SFDA (2003-2008)
Expert: The food is currently in Jiulong Water. After the medicine is separated from the Ministry of Health, the FDA has managed so well. It is better to take care of the FDA.
Leadership: It is reasonable to say that the people are eating for the day, and management should be strengthened.
2003: The State Food and Drug Administration (SFDA) was established on the basis of the State Drug Administration (SDA). In addition to the original functions, it is also responsible for the management of food, health products and cosmetics. (In fact, the function of food has not really been drawn)
Although the drug regulatory reform has achieved remarkable results, many problems have emerged in the process of reform and reform, such as the high concentration of power, the conversion of local drug approvals into some illegal activities in the process of national drug approval, and finally led to the then director of the State Food and Drug Administration. Zheng Hao was sent to the guillotine in 2007, not to mention the dream of becoming a ministerial.
The third stage: SFDA under the management of the Ministry of Health (2008-2013)
Experts: Medicine can not be separated, the food and drug administrations of developed countries in Europe and America are under the control of the Ministry of Health! No one is in charge, the Secretary has an accident.
Leader: That has to be corrected.
2008: The name of the “National Food and Drug Administration†has not changed, but the right to speak has weakened and will no longer be directly managed by the State Council and will be managed by the Ministry of Health.
Although the door was changed, the State Food and Drug Administration also served as the deputy minister of the Ministry of Health. The pharmaceutical companies felt that the change was not deep and there was only one mother-in-law. But perhaps it is more than one mother-in-law, lacking autonomy, and the relevant management systems such as drug supervision and registration are basically along the old system, and there is no major reform. The original plan for the real management of food has basically stagnated with the adjustment of the organization.
Stage 4: Independent CFDA (2013-2018)
Experts: If the medicine is not separated, the medical reform will not be pushed. Although the US FDA (the Food and Drug Administration) is affiliated with the Ministry of Health, it still works independently, and the medicine still has to be separated! One more mother-in-law, drug supervision can't keep up, the system has fallen behind many foreign countries, food supervision involves too much, and a non-direct sub-ministerial unit can't manage it.
Leadership: Since it is like this, we will separate the drug regulatory bureau and officially and uniformly manage the food.
2013: The State Food and Drug Administration was formally established, with the addition of a "total" word, which became a direct agency of the State Council (the departmental level, which has finally turned positive). It is no longer affiliated with the Ministry of Health. The English abbreviation has been changed from "SFDA". "CFDA", so far no trouble to understand, there is a "total" word, how can the English abbreviation change? In addition, the food supervision team was formally established and strengthened, and the food management function was fully incorporated into the CFDA.
At this stage, the director of the post, although not a medical background, but with the help of a group of high-level ginseng, the medical supervision and drug registration system that has accumulated over the years, although some small and medium-sized enterprises have been miserable, they have created The standardized and scientific regulatory environment has laid a solid foundation for China's pharmaceutical industry to go international, promoted innovation, improved quality, and brought hope for subsequent development.
The fifth stage: SDA (2018-?) under the State Administration of Market Supervision
expert:. . . . . .
leadership:. . . . . .
I have worked hard for decades, and I still have to take care of my mother-in-law. But this mother-in-law is no longer the familiar health planning committee. In March 2018, the State Food and Drug Administration (CFDA) canceled, no longer manage food (whether health food, cosmetics continue to be managed?), the newly established State Drug Administration is managed by the State Administration of Markets, and the independent dream is not Then, can professionalism be retained, and is the reform of the new medical policy being carried out continuing?
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