Yesterday, the State Administration of market supervision and administration announced the progress of inspection and rectification. Among them, regarding the treatment of Wuhan biological vaccines, the Party group of the General Administration of Market Supervision of the Communist Party of China believes that the accident punishment has not been strictly and severely in accordance with the relevant laws and regulations of the state, and the administrative punishment is light. The State Drug Administration, in conjunction with relevant departments and local governments, will urge enterprises to further rectify and reform, seriously investigate the responsibilities of enterprises and regulatory departments according to law, and implement seed replanting measures.
According to the unified deployment of the central government, from February 24 to May 23, 2018, the 11th Central Inspection Group inspected the Party group of the former State Food and Drug Administration. In July 20, 2018, the central eleventh inspection team feedback the inspection opinions to the party supervisory committee of the market supervision bureau. According to the Regulations on Inspection Work of the Communist Party of China and the Regulations on Supervision within the Party of the Communist Party of China, the Party group of the General Administration of Market Supervision announced the progress of inspection and rectification yesterday.
The most stringent regulation of vaccines
In the progress of rectification, the Party committee of the General Administration of market supervision said that the rectification and implementation will be carried out one by one. One of them is in the process of implementing the four most stringent requirements.
Specifically, in the most rigorous aspects: to strengthen the inspection of vaccine manufacturers, increase the strength of vaccine wholesale inspection, Listing Supervision of vaccine cases, the implementation of the most stringent supervision of vaccines. In the aspect of the most severe punishment, we should actively cooperate with the amendment of the High Law to improve the interpretation of the applicable laws for handling criminal cases against food safety, and implement the provisions on punishment for acts, punishment for persons and prohibition of entry into the industry. Strengthen the link of execution, cooperate with the Ministry of Public Security and the High Inspection Department for major illegal acts, and jointly punish with the Ministry of Public Security and other relevant departments. To study and draft notices on severely cracking down on illegal acts in the production and sale of shanzhai food, to deploy various localities to carry out control work and to crack down on relevant illegal acts.
Enhance risk control of rabies and DPT vaccine
In the aspect of the problem that some rectification tasks were not completed as scheduled, two vaccine incidents, Changsheng in Changchun and Biology in Wuhan, were discussed.
The General Administration of Market Supervision and Administration said that it was doing a good job in handling Changchun Changsheng vaccine cases. On the one hand, it actively participated in the work of the investigation team of the State Council, further increased its manpower and sent more capable people to do a good job in investigating and handling the preceding proposals and in coordinating and safeguarding the rear; on the other hand, it organized special forces in the rear and organized comprehensive work. To investigate risks, research and improve the vaccine management system, and strengthen public opinion monitoring and guidance. From July 23 to August 9, the State Drug Administration dispatched 45 inspection teams to conduct a comprehensive and thorough risk investigation on 45 vaccine manufacturers (excluding Changsheng Changchun Company) in China. According to the judgment standard of GMP for drug production, the results showed that the vaccine varieties produced by the existing enterprises were in progress. Often, no problems affecting the quality and safety of the vaccine are found, which will enhance the risk control of rabies vaccine and pertussis-tetanus vaccine.
Wuhan biological vaccine administrative penalty is light
On August 1, the State Pharmaceutical Administration, together with the Health and Health Commission and other departments, formed a verification team to go to Hubei Province to check the disposal of the Baibaibai Tetanus vaccine with the batch number 201607050-2 of the Wuhan Institute of Biological Products Limited Company, which was discovered in 2017, and to determine that the company did not operate according to the production regulations and that the local regulatory authorities existed. The State Drug Administration, together with the relevant departments and local governments, will urge enterprises to further rectify the situation, and seriously investigate the responsibility of enterprises and supervisory departments according to law and implement the measures of replanting.
In addition, the General Administration of Market Supervision said that Changchun Changsheng Problem Vaccine Case exposed many loopholes, such as inadequate supervision, weak supervision and guidance, lax checks and controls, and neglect of responsibility of the relevant staff of the former State Food and Drug Administration and Drug Administration. The responsible persons have been dealt with seriously, and the results have been announced to the public. The Party group of the State Drug Administration has also made a profound inspection to the Party Central Committee and the State Council. At present, the follow-up work of Changchun Changsheng vaccine case is being carried out urgently.
Wuhan biological DPT vaccine
More than 400 thousand failed.
In 2017, the former State Food and Drug Administration of China Food and Drug Inspection Institute found in the national drug sampling, Wuhan biological production batch number of 201607050-2 pertussis vaccine potency index does not meet the standard requirements, diphtheria, tetanus potency indicators meet the requirements. A total of 400 520 unqualified batches of vaccines were sold to Chongqing CDC 19 520 and Hebei CDC 210 000. In November 3, 2017, the former State Food and Drug Administration announced the news to the public.
After the occurrence of unqualified vaccines, the former State Food and Drug Administration requested that the use of unqualified products be stopped immediately, and ordered vaccine manufacturers to report the results of the factory inspection of unqualified vaccines, re-examine the retained samples, and seriously find out the reasons for unqualified potency. At the same time, the investigation team was sent to investigate the enterprises and carry out the compliance check of the on-site production system.
After the rectification of Wuhan Biological Company, the Central Inspection Hospital determined the titer of 30 batches of 100-tetanus-white vaccine produced continuously by Wuhan Biological Company. The results all met the requirements and resumed production in combination with on-site inspection.
Source: Beiqing Net - Beijing Youth Daily editor in charge: Li Cong _B11284