CCTV News:Following the announcement issued by National Medical Products Administration on July 15th that Changchun Changsheng Bio-freeze-dried rabies vaccine for human use was produced with false records, on the morning of 16th, Changsheng Bio-announced that all batches of freeze-dried rabies vaccine for human use were being recalled within the validity period.
Changsheng Bio announced that at present, Jilin Food and Drug Administration has recovered Changchun Changsheng’s GMP Certificate, and Changchun Changsheng has stopped the production of rabies vaccine as required. All batches of products involved in this flight inspection have not yet left the factory and gone on sale, and all products have been effectively controlled. In order to ensure the safety of medication, Changchun Changsheng is recalling all batches of freeze-dried rabies vaccine for human use within the validity period. According to the monitoring of adverse reactions of the rabies vaccine by Changchun Changsheng in recent years, no adverse reactions caused by product quality problems were found.
Changchun Changsheng will strictly implement the requirements of the regulatory authorities, actively cooperate with the regulatory authorities to carry out a comprehensive self-examination of the production and quality control system, take effective measures in time to eliminate hidden dangers in production quality, and seriously strengthen quality control.
Changchun Changsheng deeply apologized for the occurrence of this incident. Changchun Changsheng will closely follow the progress of the incident and actively cooperate with National Medical Products Administration, Jilin Food and Drug Administration and other relevant regulatory authorities to carry out follow-up work.
Has anyone injected the vaccine? This batch has not yet left the factory.
For the public, the most concerned question is: has anyone injected this batch of rabies vaccine? According to the announcements made by National Medical Products Administration and the companies involved, all the products involved in this inspection have not yet left the factory and gone on sale, and all the products have been effectively controlled.
Several major questions have attracted much attention.
To pay attention to several major questions that have attracted much attention in this incident.
How is fraud exposed?
First of all: How was the vaccine problem discovered? According to the announcement issued by National Medical Products Administration on July 15th, the reason for finding the problem was "to carry out flight inspection on Changchun Changsheng according to clues".
What is "flight inspection"
Also: So what is "flight inspection"?Flight inspection is actually a surprise inspection with strong confidentiality and high efficiency. Especially for the inspection of reporting, compared with the previous follow-up inspection that notified the inspected enterprises in advance, flight inspection is a powerful means to break local protection, expose and crack down on hidden rules of the industry, and severely punish violations of laws and regulations.
What records are fraudulent? Under investigation.
The other thing is, what problems have you found?National Medical Products Administration’s notice said that it was found that the company’s production of freeze-dried rabies vaccine for human use had serious violations of the good manufacturing practice, such as falsification of records. So which records in the production process are falsified? It is still under investigation. However, at present, Jilin Food and Drug Administration has withdrawn the GMP Certificate of this enterprise, which means that the freeze-dried rabies vaccine for human use applied by this factory has been discontinued.
At present, National Medical Products Administration has sent a special inspection team to Jilin to supervise the investigation and disposal. We will continue to pay attention to the relevant survey results.