laitimes

Another official of the former Food and Drug Administration fell from power to "effectively prevent critical incidents" and the Department of Registration Management & Supervision of Vaccine Incidents

Written by | Dong Xin

At 7 p.m., when the news broadcast had just begun, the State Administration of Market Regulation issued a notice of dismissal:

Wang Lifeng, former director of the Department of Drug and Cosmetics Registration and Administration of the State Food and Drug Administration (Department of Supervision of Traditional Chinese Medicines and Ethnic Drugs), is suspected of serious violations of discipline and law and is currently under disciplinary review and supervision and investigation.

After the "Changchun Vaccine Case", Wang Lifeng was the second person to fall from the original Food and Drug Administration system.

Another official of the former Food and Drug Administration fell from power to "effectively prevent critical incidents" and the Department of Registration Management & Supervision of Vaccine Incidents

On August 16, the central government carried out the "strongest accountability" for the Changchun Changsheng Company's problem vaccine case, and Wu Hun, former deputy director of the State Food and Drug Administration, was informed that he was subject to disciplinary review and supervision and investigation by the Central Commission for Discipline Inspection and the State Supervision Commission.

<h1>"Effective prevention of critical incidents"</h1>

Time back 9 years.

In February 2009, the State Food and Drug Administration Inspection Work Conference was held, and Wang Lifeng, as the director of the Inspection Bureau of the State Food and Drug Administration, attended the meeting and delivered a speech.

Wang Lifeng demanded that the food and drug regulatory inspection should change the work idea from "properly handling drug harm incidents" to "effectively preventing drug harm incidents".

The first is to find the direction of risk prevention. Especially in underdeveloped areas and grass-roots rural areas, the quality of drugs in the circulation link and the quality of high-risk drugs such as injections are more likely to be sudden drug harm incidents, and efforts should be made to strengthen supervision in these key areas, key links and key varieties.

The second is to strengthen the collection and evaluation of drug risk information. In particular, it is necessary to pay attention to drug risk information with clear direction and high accuracy, such as "reporting by insider insiders" and "centralized reporting for a certain product", assess the products or enterprises with greater risk, take the initiative in a targeted manner, and increase supervision and sampling.

Wang Lifeng also said that the food and drug regulatory inspection should take precautions, prevent problems before they occur, and minimize the losses suffered by the masses in drug harm incidents.

<h1>Fallen officials with vaccine incidents</h1>

More than a year after the meeting, two vaccine outbreaks broke out.

One is the familiar Shanxi "labeled vaccine" incident, and the other is In Jiangsu.

On April 2 of that year, the former State Food and Drug Administration also announced the results of a survey of a vaccine case in Jiangxi, saying that Yanshen Company had cut corners, cheated and evaded supervision in the process of producing rabies vaccines for human use, so that unqualified products flowed to the market, and the local public security department had filed a case for investigation.

On the morning of April 6, the former Ministry of Health and the former State Food and Drug Administration held a press conference on the "labeled vaccine" incident in Shanxi. On behalf of the former Food and Drug Administration, Wang Lifeng, who was still the "Director of the Inspection Bureau of the State Food and Drug Administration" at that time, attended the press conference.

At that time, there were rumors that Wei Liang, a researcher in the Biological Products Division of the Drug Registration Department of the State Food and Drug Administration, had been "shuanggui". At the press conference, a reporter asked Wang Lifeng to verify this matter and asked whether some officials of the drug regulatory system were involved in the vaccine incident.

Wang Lifeng has repeatedly stressed that it is just a "coincidence of time" and that corruption has nothing to do with vaccines.

However, this explanation is slightly far-fetched.

Wei Liang has served in the former Department of Drug Registration and the Department of Drug Safety Supervision of the State Food and Drug Administration, and his work is related to vaccines and blood products.

In November 2010, seven months after the press conference, Wei Liang was indicted by the Dongcheng District Procuratorate of Beijing Municipality for accepting bribes of more than 1.47 million yuan for allegedly violating the law by helping 25 companies in drug registration and approval.

<h1>Registry Management Division &amp; Regulatory Division</h1>

After the last round of institutional reform, in the internal departments of the former State Food and Drug Administration, the two departments that Wei Liang once served in were renamed the Department of Registration and Administration of Drugs and Cosmetics (Department of Supervision of Traditional Chinese Medicines and Ethnic Drugs) and the Department of Supervision of Drugs and Cosmetics.

A search of the official website of the former Food and Drug Administration found that both departments were vaccine-related.

The Department of Registration Administration shall undertake the evaluation of the vaccine regulatory quality management system and the administrative protection of drugs.

The Supervisory Division takes on more work. The Special Drug Supervision Department under it shall formulate quality management norms for vaccines, produce and operate inspection systems and supervise their implementation, organize supervision and inspection of vaccine production and circulation, and take timely measures to deal with the problems found.

On August 18, the State Administration for Market Regulation held seven relevant staff members accountable, five of whom were from the Department of Drug and Cosmetics Supervision.

Ding Jianhua, former director of the Department of Drug and Cosmetics Supervision of the State Food and Drug Administration (STATE FOOD AND DRUG Administration) and director of the Food and Drug Audit and Inspection Center, was dismissed from his post;

Dong Runsheng, former deputy director of the Department of Drug and Cosmetics Supervision of the State Food and Drug Administration (STATE FOOD AND DRUG Administration), was dismissed from his post;

Sun Jinglin, former deputy director of the Department of Drug and Cosmetics Supervision of the State Food and Drug Administration (WHO) (former deputy director of the Food and Drug Audit and Inspection Center of the State Food and Drug Administration from November 2014 to April 2017), was dismissed from his post;

Ye Guoqing, former director of the Special Drug Supervision Division of the Drug and Cosmetics Supervision Department of the State Food and Drug Administration (STATE FOOD AND DRUG Administration), was dismissed from his post;

Guo Xiuxia, a former researcher in the Special Drug Supervision Division of the Drug and Cosmetics Supervision Department of the State Food and Drug Administration (STATE FOOD AND DRUG Administration), was dismissed from his post.

Wang Lifeng is the first person in charge of the Department of Drug and Cosmetics Registration Management to be held accountable after the vaccine case.

After the institutional reform, Wang Lifeng is currently the director of the Department of Drug and Cosmetics Registration of the State Drug Administration.

The last public appearance was on the afternoon of June 22 this year, when he accompanied Jiao Hong, director of the State Drug Administration, to a press conference held at the Information Office of the State Council to introduce the work related to accelerating the review and approval of new drugs listed overseas.

At that time, there were still more than 3 weeks before the "Changchun Vaccine Case" was detonated.

However, whether Wang Lifeng is related to the "Changchun Vaccine Case" has yet to be further disclosed by the official information.

Information | Xinhua News Agency, Times Weekly, etc

Proofreading | Li Zhe