According to CCTV news reports, the head of the State Food and Drug Administration today informed Changchun Changsheng Biotechnology Co., Ltd. about the illegal production of freeze-dried human rabies vaccine cases.
According to the clues provided by the report, on July 5, the State Food and Drug Administration and the Jilin Provincial Bureau conducted a flight inspection of Changchun Changsheng Company; on July 15, the State Food and Drug Administration and the Jilin Provincial Bureau formed an investigation team to conduct comprehensive investigations. On July 15, the State Food and Drug Administration issued the "Notice on Changchun Changsheng Biotechnology Co., Ltd.'s illegal production of freeze-dried human rabies vaccine."
It has been found that the company fabricates production records and product inspection records, and arbitrarily changes process parameters and equipment. The above acts are a serious violation of the relevant provisions of the Drug Administration Law of the People's Republic of China and the Regulations on the Quality Management of Pharmaceutical Production. The State Food and Drug Administration has ordered enterprises to stop production, recover the GMP certificate for drugs, and recall unused rabies vaccines.The State Food and Drug Administration and the Jilin Provincial Bureau have filed investigations on enterprises, and the suspected crimes have been transferred to the public security organs for criminal responsibility.
According to the relevant regulations on vaccine management, the vaccines for sale and marketing of all enterprises must be submitted to the China Food and Drug Control Research Institute for approval. The safety of all batches of vaccines should be tested during the batch issuance process, and the effectiveness of a certain proportion of batches of vaccines should be tested. . The company has been legally tested for the sale and use of vaccines, and no quality problems have been found. In order to further confirm the effectiveness of the vaccines already on the market, a laboratory evaluation of sample samples of enterprise samples has been initiated.
According to the monitoring by the Chinese Center for Disease Control and Prevention, the incidence of rabies in China has gradually declined in recent years.
The Food and Drug Administration has deployed national vaccine production enterprises to conduct self-inspection to ensure that enterprises organize production according to the approved technology, strictly abide by GMP production standards, and all production inspection process data should be true, complete, reliable and traceable. The State Food and Drug Administration will organize the flight inspection of all vaccine production enterprises, and seriously investigate and deal with violations of laws and regulations.
The person in charge said that the company was the second time in a year to discover the quality of product production. In October last year, the original food and drug supervision bureau found in the sampling test that the batch of Baibai broken vaccine produced by the company was unqualified, and the product is still in production. The former National Health and Safety Commission and the original food medicine are related to the replanting work. The General Administration of Supervision has deployed in February this year.
Changsheng Bio (002680) replied to the Shenzhen Stock Exchange on the evening of July 22nd. At present, the company's Baibai broken production workshop has been discontinued. The company is actively researching the Baibai broken component vaccine and the multi-linked vaccine based on it. We feel very guilty about the occurrence of this incident and once again express our deep apologies to the vaccinators and investors. The company will take the lead and make a correct and corrective measure to thoroughly rectify the production, ensure the compliance, authenticity, reliability, traceability and safety of the vaccine.
Changsheng Bio said that due to the rabies vaccine incident, it is expected to have a negative impact on the sales of other products of the company, but it is not yet accurately predicted. According to the current situation, some local disease control agencies temporarily suspended other company vaccine products.
Changsheng Bio said that after the company self-examination, it did not receive the notice of filing investigation issued by Jilin Food and Drug Administration; in addition, in 2016 and 2017, the income of DTP vaccine did not reach the 9.2 “Stock Listing Rules” of the Shenzhen Stock Exchange. The stated revenue is 10%, so the company judges that the matter is not a material that should be disclosed.
The following is the full text of the reply announcement:
In addition, Changsheng Biotech also disclosed a correction notice for the reply to the Shenzhen Stock Exchange's 2017 annual inquiry letter. Due to staff negligence, the freeze-drying human rabies vaccine was issued in 2016 and 2017 in batches. The amount is statistically incorrect. After the amendment, the number of batches issued in 2016 and 2017 increased, and a total of 460,000 people were added in two years.
The following is the full text of the correction announcement: