Changchun Changsheng rabies vaccine production records were falsified, and an investigation has been initiated!

As is well known, rabies vaccines used for human disease prevention are meant to ensure the safety of people's lives, and no carelessness is tolerable. Recently, Changchun Changsheng, the "core" subsidiary of the A-share listed company Changsheng Bio-technology, was placed under court investigation and had its drug GMP certificate revoked due to illegal and non-compliant acts such as falsified production records for freeze-dried human rabies vaccine (Vero cell).

Changchun Changsheng was founded in 1992. Its currently marketed products include freeze-dried live attenuated varicella vaccine and freeze-dried rabies vaccine for human use (Vero cell). In terms of batch release volume, its rabies vaccine and varicella vaccine rank second in China. These two types of vaccines are divalent vaccines and also serve as the company’s core profit drivers. Data shows that in 2017, Changsheng Biological achieved revenue of 1.553 billion yuan, while Changchun Changsheng’s revenue during the same period was approximately 1.539 billion yuan, accounting for 99.1% of the listed company’s total revenue.

On the evening of July 15, the National Medical Products Administration issued a notice stating that during an unannounced inspection of Changchun Changsheng, it was found that the company's production of freeze-dried human rabies vaccine involved serious violations of the Good Manufacturing Practice for Drugs, including falsification of records, and ordered the company to stop producing rabies vaccines.

Before the National Medical Products Administration issued the notice, the media had already been following the matter. When verifying with a staff member of Changsheng Biotechnology's medical consulting department, the staff member said, “It was not the drug regulatory authorities that found problems; it was our own action. Perhaps we were concerned that there might be some issues with our previous quality indicators, so we decided to recall the products and test the current indicators on the market.”

In an announcement released today, Changsheng Biological stated that based on Changchun Changsheng's monitoring of adverse reactions to the freeze-dried human rabies vaccine (Vero cell) in recent years, no adverse reactions caused by product quality issues have been found.

"We are not lacking in pharmaceutical technology; the issue is that our focus has not been on quality, and we lack the most basic reverence for life." Pharmaceutical writer Liu Qian stated that although the specific details are unclear, the immediate revocation of the company's GMP certificate and the recall of its products by the National Medical Products Administration already indicate that the problem is very serious.

Therefore, for the falsification of records in the production of rabies vaccines by Jilin Changchun Changsheng Biotechnology Co., Ltd., strict punishment must be imposed according to the law, with no leniency. It is gratifying that in recent years, the state has successively introduced a series of laws and regulations to regulate vaccine issues.

On April 25, 2016, the State Council issued a decision to amend the Regulations on the Administration of Vaccine Circulation and Preventive Vaccination, specifying that vaccination units shall not directly purchase Category II vaccines from enterprises, and that the state shall establish a whole-process vaccine traceability system.

On February 7, 2017, the General Office of the State Council issued the Opinions on Further Strengthening the Management of Vaccine Circulation and Vaccination, which explicitly called for promoting vaccine manufacturers to improve their quality management and standardize their production capacity, so as to continuously enhance the quality of vaccine products.

In response to the Changchun Changsheng incident, the National Medical Products Administration made it clear that "no leniency will be shown for any violations of laws and regulations that are discovered, and strict investigation and punishment will be carried out in accordance with laws and regulations. Any suspected criminal activity will be transferred to public security organs for severe punishment." For more legal knowledge, you are welcome to click on the online consultation of Guangdong Zhiming Law Firm.

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