Chinese drug regulator launches investigation of all vaccine manufacturers


The National Drug Administration of China (CNDA) launched a thorough investigation into all vaccine producers across the country. Local authorities have arrested 15 people including the chairwoman of a vaccine producer under fire for fraudulent quality control in the country’s latest drug-safety scandal.

Changchun Changsheng Life Sciences Limited, a Chinese vaccine maker, was subject to an unannounced inspection by the local regulatior and Jilin provincial food and drug bureau on July 6 and July 8 following a tip-off.

Chinese drug producer, Changchun Changsheng, had violated standards in making at least 250,000 doses of vaccine for diphtheria, tetanus and whooping cough (DPT).

On July 15, CNDA launched a thorough investigation into all vaccine producers across the country. Chinese drug producer had violated standards in making of DPT vaccine. announced that the company had illegally produced freeze-dried human rabies vaccines after a comprehensive investigation the same day. The inspection found that the company had fabricated production and inspection records, and arbitrarily changed process parameters and equipment during its production of freeze-dried human rabies vaccines.

From July 25, CNDA teams will be dispatched to thoroughly investigate the whole process and entire chain of vaccine production of all vaccine. The investigation is conducted after an earlier examination of 45 vaccine producers that began at the beginning of the year, and follows an illegal vaccine production case revealed recently.

The CNDA had revoked the company’s drug GMP certificate following its serious violations of relevant law and regulations, and demanded a recall of unused vaccines. According to SDA, none of the batches of human rabies vaccines examined during the recent unannounced inspection have left the factory and are not sold on the market.