Changsheng Biological Technology Co., Ltd. (002680.SZ hereinafter referred to as Changsheng Biological) rabies vaccine involved in illegal production incidents continued to ferment.The Changchun New District Public Security Bureau issued a notice on July 23 stating that at 15:00 p.m., the Changsheng Bio freeze-dried rabies vaccine for human use was suspected of criminal investigation.review.At present, relevant departments have not disclosed details of violations of laws and regulations in vaccine production.
A person close to Changsheng Biology told the Caixin reporter that Gao Junfang was taken away by the public security organs this afternoon and has not returned.
The reporter of Caixin learned that according to the clues of the report, the State Food and Drug Administration went to Jilin twice to conduct unannounced inspections on longevity organisms starting from July 5, and issued a notice of the inspection results to the company at 12:00 on July 13.Senior executives of Changsheng Biology rushed to Jilin Provincial Food and Drug Administration to communicate with each other that night.Since then, the State Food and Drug Administration and the Jilin Provincial Food and Drug Administration organized experts and staff to send investigation teams to the enterprise.By July 19, the investigation team had withdrawn from the enterprise.
On July 15, the State Food and Drug Administration officially issued a notice.According to the notice, after an unannounced inspection based on clues, it was discovered that the rabies vaccine produced by Changchun Changsheng Biotechnology Co., Ltd. (a wholly-owned subsidiary and business entity of Changsheng Biotechnology) was found to have problems such as falsification of production records, and has been ordered to stop production and withdraw the GMP certificate.(Certificate of Good Manufacturing Practice).The State Food and Drug Administration stated that all batches of vaccines involved in the company have been controlled.However, on the day of the incident, the company recalled all vaccines that were on the market within the validity period.
Which aspects of the production records of the enterprise are suspected of being falsified, and why?The limited information has been deduced several times, and the speculation of public opinion has fermented rapidly.The public's trust in the safety and effectiveness of domestic vaccines has been severely damaged.
On the evening of July 22, the person in charge of the State Food and Drug Administration made his first public appearance to introduce the case.The announcement stated that Changchun Changsheng fabricated production records and product inspection records, and changed process parameters and equipment at will, which violated the relevant provisions of the Drug Administration Law of the People's Republic of China and the Good Manufacturing Practice for Drugs., Those who are suspected of committing a crime will be transferred to the public security organ for criminal responsibility.
It is worth noting that when the State Food and Drug Administration reported this time, it also explained the vaccine inspection process, pointing out that: According to the relevant regulations on vaccine management, all vaccines marketed by enterprises must be reported to the China Institute for Food and Drug Control (below)During the batch release process, the safety of all batches of vaccines must be tested, and the effectiveness of a certain proportion of batches of vaccines must be tested.The vaccines used by the company for sale on the market have all passed statutory inspections, and no quality problems have been found.
However, the State Food and Drug Administration also stated that in order to further confirm the effectiveness of the vaccines that have been marketed, it has initiated laboratory evaluation of samples of products reserved by enterprises.
At present, the State Food and Drug Administration, public security organs and Changsheng Biotech have not disclosed the specific details of Changsheng Biology’s rabies vaccine production violations.Many industry insiders analyzed to the Caixin reporter that this was related to Changsheng Biotechnology’s private adjustment of the production process and failure to produce according to GMP standards.
On the evening of July 22, Premier Li Keqiang of the State Council issued instructions on the vaccine incident: The vaccine incident broke through the bottom line of human morality, and a clear and clear explanation must be given to the people of the whole country.Li Keqiang also stated in the instructions that the State Council should immediately send an investigation team to conduct a thorough investigation of the entire process and chain of all vaccine production and sales, and find out the truth as soon as possible.No mercy.
On July 23, the leader of the National President gave instructions on the Changsheng biological vaccine case, pointing out that the progress of the investigation should be announced in a timely manner to effectively respond to the concerns of the masses.The Chinese leader stated that the relevant localities and departments should attach great importance to it, immediately investigate the truth, investigate to the end, seriously hold accountable, and deal with it strictly according to law.■
