Food and Drug Administration that has passed away: Ups and downs 40 years...

Medical Network News March 15

'Food and Drug Administration, about to die'

After the State Council’s institutional reform program was announced on March 13, a person who had worked in the drug surveillance system for three years expressed emotion.

In 2008, when the State Food and Drug Administration was placed under the original Ministry of Health, this person wrote on his blog a blog post titled “The Food Bureau is gone, lost” describing his mood at the time:

After working in the SFDA system for three years, the disappearance of his independent identity has caused me some loss.

10 years later, in 2018, the history of the past was repeated in a similar way. He had no sense of loss.

'The status of the pharmaceutical industry is not the same as the status of the society. Even if it drops the vice ministerial level, its professional attributes, its achievements in reforms in recent years will certainly continue. Otherwise, everyone does not agree,' he told Cypress. Blue said.

In the 40 years of reform and opening up, the drug regulatory agencies at the national level (Note: We have changed the predecessor of the Bureau of Food and Drug Administration by default from the Pharmaceutical Administration) for eight changes.

First, the General Drug Administration was established in 1978, directly under the State Council.

Second, in 1982, it was renamed the State Administration of Pharmaceuticals, and was placed under the former Economic and Trade Commission.

3. In 1988, the State Administration of Pharmacy was directly subordinate to the State Council.

Fourth, in 1994, the State Administration of Pharmacy was placed under the former Economic and Trade Commission.

Fifth, in 1998, the State Drug Administration was established directly under the State Council; in 2003, the State Food and Drug Administration was established.

6. In 2008, the State Food and Drug Administration was assigned to the former Ministry of Health.

Seventh, in 2013, the new State Food and Drug Administration, directly under the State Council.

Eighth, in 2018, the State Drug Administration was established and it was placed under the newly established National Market Supervision Administration.

By the morning of March 13th, when the news came out, the State Food and Drug Administration would no longer be retained. The drug supervisor had travelled in China for a full 40 years.

In 1978, the curtain of reform and opening up was opened in China. In July of the same year, the State Administration of Pharmaceutical Administration was established as an institution directly under the State Council. The main task is to end the current situation of the division of the bar and form a unified pharmaceutical supervision system.

However, four years later, in 1982, the State Administration of Pharmaceuticals was changed to the State Administration of Pharmaceuticals. It was placed under the former State Economic Commission and became the competent department of pharmaceutical industrial and commercial enterprises. It is no longer a subsidiary of the State Council.

In 1988, the State Administration of Pharmacy was reorganized into a subsidiary directly under the State Council. In 1994, the State Administration of Pharmacy returned to the former State Economic and Trade Commission.

It is not difficult to see that in the past 12 years, China's drug regulation has been constantly adjusted and changed. After a long period of change and exploration, China's drug administration began to enter an orderly growth stage.

On April 16, 1998, the State Drug Administration merged with the Department of Drug Administration of the former Ministry of Health to absorb some of the functions of the State Administration of Traditional Chinese Medicine and formed the State Drug Administration (Department of Ministers).

This is a historic and dramatic change. Although it is only a sub-ministerial unit, the word “medicine” has been removed from the name of the organization, emphasizing the specificity of 'drugs'. However, it has since opened up 20 years of new drug regulatory supervision. The journey, since then 'drug supervisor' officially entered the stage of history.

However, in the pharmaceutical industry, people did not have a big expectation for the newly established drug administration department. In those years, China was still the world's raw material drug, generic drug industry, 'the level of innovation is not high, the transition requirements are not strong, and policy changes are not so Frequently, the profitability of pharmaceutical companies is also relatively large.'

In addition, although the organization has been reformed, the head of the organization has not changed – Zheng Zheng has been the director of the State Administration of Pharmacy since 1994. He was removed from the position of Director of the Food and Drug Administration in 2005 and has been the head of the government for 11 years.

After the establishment of the Food and Drug Administration, it did two major things. First, it forced the promotion of GMP and GSP certification. Second, drug registration was integrated into the national unified management. The provinces and municipal food and drug regulatory bureaus can no longer return to the era of drug approval.

According to Guo Taihong, former president of the Zhejiang Pharmaceutical Industry Association, the effect of the reform of the national administrative agency that responded to the market economy system was obvious:

First, the enterprise has returned to the original nature of the market. It has provided goods, formed jobs, created profits, turned taxes on its own responsibility, and was responsible to the investor.

Second, the government has returned to the basics of market supervision. According to the peculiarities of drugs, it supervises the quality, safety and efficacy of drugs, and is responsible to society and the market.

In 2003, with the approval of the State Council, the State Food and Drug Administration was established on the basis of the State Drug Administration.

Although the reform did not involve a drastic change in the functions of drug supervision, it has increased the supervision of food. The expansion of jurisdiction has made the task of drug supervision more arduous.

At the same time, vertical management is implemented for drug regulatory agencies under the province, and unified supervision is strengthened. The overall principle of responsibility for food and drug safety is established for 'local governments responsible for the overall responsibility, supervision departments are responsible for each other, and the company is the first responsible person'.

During this period, the drug supervisors had a good sense of 'self-feeling' in the civil service.

Although significant achievements have been made in drug regulatory reforms, many problems have also emerged in the process of reforms and restructurings, such as high concentration of power, serious drug approvals, and landmarks for approval of pharmaceuticals, as well as the search for rent for state-owned power. Zheng Wei, director of the State Food and Drug Administration, was executed to death.

In 2008, China began to carry out major reforms, and drug supervisors were also 'reformed'. The institutions directly under the State Council became the agency of the original Ministry of Health, and they again lost the legislative power of the department's regulations.

The former Ministry of Health was responsible for the formulation of national drug laws and regulations, advancing the national essential medicine system, and handling major drug safety accidents.

As a result of changes at the national level, the Food and Drug Administration at the provincial level has also begun to undergo changes - from vertical management to local government decentralization governance, with local responsibility.

In 2013, the State Food and Drug Administration changed to the State Food and Drug Administration and became a subsidiary directly under the State Council. It is no longer under the Ministry of Health. This is also the first time that the pharmaceutical supervisor has entered the ranks of ministerial units.

In this reform, drug supervisors summarized their institutional responsibilities with the words “four products, one weapon,” Health products , Food, Food, cosmetic , medical instruments The whole process of production and circulation supervision.

Two years after the General Administration of Food and Drugs appeared, Bi Jingquan took office as CFDA director, and promoted the reform of food and drug 'storm'.

Born in 1955, a strong reformer graduated from the Faculty of Economics of Peking University in 1982. Prior to becoming the director of the CFDA, he served as Deputy Secretary-General of the State Council for 7 years, and worked in the NDRC system for 26 years. He was the deputy director of the Development and Reform Commission.

In the three years since the completion of Bi Jingquan’s Administration and Food and Drug Administration, there are four 'core documents' that have far-reaching implications for the pharmaceutical industry. They are:

In August 2015, the State Council issued "About the Reform drug "Opinions on reviewing, approving and approving systems for medical devices";

February 2016, Opinions on the Conformity Assessment of Quality and Efficacy of Generic Drugs issued by the General Office of the State Council;

In February 2017, the “13th Five-Year National Drug Safety Plan” issued by the State Council;

In July 2017, the Central Leading Group for the Comprehensive Deepening of Reforms passed the review. On October 8, the General Office of the State Council issued the "Opinions on Deepening the Reform of the Evaluation, Approval, and Approval System to Encourage the Innovation of Pharmaceutical Medical Devices."

In addition, he also did two key tasks. One was the November 2015 National People's Congress Standing Committee's approval of 10 provinces and cities to launch the pilot program for the holders of drug marketing licenses; the other was the approval of the CFDA by the State Council in June 2016. International Human Drug Registration Technical Coordination Council (ICH).

In addition, on the supervision of pharmaceuticals, a national and provincial inspection team has also been established to form a combination of daily inspections, sampling inspections, and flight inspections.

Some commentators said that Bi Jingquan is not medicine His origins have created a normative and scientific regulatory environment for the pharmaceutical industry, laying a solid foundation for the Chinese pharmaceutical industry to go international.

In his New Year's address on December 31, 2017, Bi Jingquan commented on the achievements of the food and drug monitoring system of the past year: 'Solved many problems that we had long wanted to solve but did not solve. Into the big event'.

It can be said that the General Administration of Food and Drugs is approaching the goal of reform—to ensure the safety, effectiveness, and controllability of drugs, and to comply with international standards.

Some insiders commented that: From SDA to SFDA, CFDA, the Food and Drug Administration has changed for five years, mainly in the form of regulatory innovation, and the regulatory role of actual drugs has not changed.

In addition, the State Market Supervision Administration will integrate the responsibilities of several major antitrust agencies and will effectively crack down on the use of prices, mergers and acquisitions, abuse of monopolistic companies, and the introduction of government agencies that impede fair competition.

At 9 o'clock in the morning on March 13 this year, the first session of the 13th National People's Congress held its fourth plenary session in the Great Hall of the People. The State Council's institutional reform plan was submitted for consideration.

According to the plan, after the reform, the General Administration of Market Supervision and Administration was established as a subsidiary of the State Council. The State Food and Drug Administration, the State Administration for Industry and Commerce, and the General Administration of Quality Supervision, Inspection and Quarantine no longer remain.

However, taking into consideration the special nature of drug supervision, the State Drug Administration shall be established separately and administered by the State Market Supervision Administration. The market supervision shall be managed in stages, the drug regulatory agencies shall be set up only at the provincial level, and the regulation of drug sales and sales shall be conducted by City and county market supervision departments to take the responsibility.

"This round of reforms of food and drug regulatory agencies truly embodies the top-level design. It is beyond the supervision of the departments to carry out reforms. It is a new climate in the new era." Hu Yinglian, a professor at the National School of Administration, believes that any reform plan has advantages and challenges.

The 'big market-special drug' model captures two key aspects of current food safety management: the coordination and comprehensiveness of food safety supervision, and the particularity and professionalism of drug supervision.

However, Hu Yinglian also particularly emphasized: 'Our understanding of reforms should not be limited to the narrow perspectives of institutional separation, mergers and reorganizations, and there should be no problem of 'who joins who', but an institutional paradigm reform in the context of the modernization of state governance. . '

As a former drug supervisor, I believe that regardless of how the organization is reformed, the Food and Drug Administration will always do a good job of escorting citizens' life and health. The former drug supervisor mentioned by Wen Wen said, 'In a conscience, currently The pharmaceutical supervision is the best period in history. It not only takes into account the people's side, but also serves the industry's scientific growth.

For 2018, Bi Jingquan once looked forward to this: The new year must have a new atmosphere, and even more must be new. Under the changes, the drug supervisor will also begin a new prelude.

Some people in the industry say that we are on the way from a big pharmaceutical country to a pharmaceutical power. Whether it is a drug supervisor or a medical person, we need to start again after 40 years of reform.