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

[2] As is well known, rabies vaccines used for disease prevention in humans are meant to ensure the safety of people's lives and allow no room for negligence. Recently, Changchun Changsheng, the "core" subsidiary of A-share listed company Changsheng Biotechnology, was placed under court investigation and had its GMP certificate revoked due to illegal activities such as falsification of production records for freeze-dried human rabies vaccine (Vero cells).

[3] Founded in 1992, Changchun Changsheng currently sells products including freeze-dried live attenuated varicella vaccine and freeze-dried human rabies vaccine (Vero cells). In terms of batch release numbers, its rabies and varicella vaccines rank second domestically. These two vaccines are bivalent and serve as the company's core profit drivers. Data shows that in 2017, Changsheng Biotechnology achieved revenue of 1.553 billion yuan, while Changchun Changsheng's revenue was approximately 1.539 billion yuan, accounting for 99.1% of the listed company's total revenue.

[4] 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 had seriously violated the "Good Manufacturing Practice for Pharmaceutical Products" by falsifying production records for freeze-dried human rabies vaccine, and ordered a halt to rabies vaccine production.

In fact, before the National Medical Products Administration issued the notice, the media had already taken notice of this matter. When verifying with a staff member from the Medical Advisory Department of Changsheng Biotechnology, the staff member said, "It wasn't the drug regulatory authorities that found the problem; it was our own actions. Possibly due to concerns about some issues with our previous quality indicators, we are recalling the products to test the current market indicators."

In the announcement released today, Changsheng Biotechnology stated that based on the 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 don't lack the technology to make drugs; we just don't focus on quality and lack the most basic reverence for life," said medical writer Liu Qian. Although he is unclear about the specific details, the fact that the National Medical Products Administration immediately revoked the company's GMP certificate and recalled the products indicates the severity of the issue.

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 Vaccination," clarifying that vaccination units must not directly purchase second-class vaccines from enterprises, and the state established a full 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," clarifying the need to promote vaccine manufacturers in improving quality management levels and standardizing production capabilities, continuously enhancing vaccine product quality.

In response to the Changchun Changsheng incident, the National Medical Products Administration explicitly stated that "illegal and non-compliant issues found will not be tolerated, and will be strictly investigated and dealt with according to laws and regulations; those suspected of constituting crimes will all be transferred to public security organs for severe punishment." For more legal knowledge, welcome to click on the online consultation of Guangdong Zhiming Law Firm.

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