China: Drug regulator clears 45 vaccine makers in sweeping, scandal-triggered inspections

16 Sep, 2018
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When Changchun Changsheng Life Sciences’ manufacturing malpractice sparked a nationwide outcry over vaccine safety in July, the Chinese drug authority dispatched teams to inspect all other vaccine companies. Now, the results are in.

China’s recently rebranded National Medical Products Administration (NMPA) said (Chinese) on Friday it had inspected all of the other 45 vaccine makers between July 23 and Aug. 9 and found no quality or safety problems.

Among the 45 manufacturers, 38 were complying with GMP practices and other regulations, while the other seven have ceased production for more than three years and have no products currently on the market, said the agency.

The drug regulator said teams made “comprehensive” inspections on all those companies, including on equipment maintenance, quality control, production and material management, with a stress on the authenticity of production records and laboratory results.

Changsheng was found to have systematically fabricated production data for its rabies vaccines and had earlier provided about half a million doses of ineffective DTaP vaccines for children.

RELATED: Systematic data fabrication: Chinese police seek to arrest 18 in vaccine scandal

The scandal quickly took over the spotlight on social media as citizens voiced their criticism against the company as well as government officials’ handling of the event.

In an attempt to quell public anger and restore the image of the country’s pharmaceutical industry, dozens of senior officials at the national drug agency and provincial and municipal government bodies have been sacked or resigned, while dozens more were held accountable. These include the resignation of former China FDA chief Bi Jingquan—who had been promoted to a more powerful position before the debacle—and an anti-corruption investigation against Wu Zhen, who was No. 2 at the agency.

This entry was posted on Sunday, September 16th, 2018 at 9:59 am and is filed under Latest News.

Literature Literature archive

Lee TH, McGlynn EA, Safran DG. 2019 JAMA 321(6):539–540. doi:10.1001/jama.2018.19186
MJ Bayefsky, LOGostin 2018 JAMA Pediatr. online Dec 28, 2018. doi:10.1001/jamapediatrics.2018.4283
K I Hammanyero, S Bawa, F Braka, et al. 2018 BMC Public Health Vol 18 (Suppl 4) :1306

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