ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

ResourcesResearch IntegrityTop Chinese rabies vaccine maker ordered to stop production over forged data – FiercePharma (Angus Liu | July 2018)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Top Chinese rabies vaccine maker ordered to stop production over forged data – FiercePharma (Angus Liu | July 2018)

 


View full details | Go to resource


China’s drug regulator just pulled a manufacturing permit for the country’s second-largest maker of rabies vaccines over data falsification, marking the latest episode in China’s drug safety scandal.

During an inspection, China’s State Drug Administration found Changchun Changsheng Life Sciences forged production records for its Vero cell-based rabies vaccines. The agency immediately moved to revoke the company’s GMP license tied to the vaccine—just three months after its issuance—and dispatched a team to investigate the incident on site, according to a Sunday statement (Chinese).

In its announcement filed to Shenzhen Stock Exchange, the Changchun, China-based company said it has started recalling all unexpired rabies vaccines, even though the batches under question weren’t released to the market, and it hasn’t received any adverse event report related to the quality of the vaccines through years of monitoring.

Read the rest of this discussion piece



Resources Menu

Research Integrity


Human Research Ethics