Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Jiangxi Boya Bio-Pharmaceutical Disputes Responsibility In Drug Deaths

This article was originally published in PharmAsia News

Executive Summary

China's State FDA is overseeing the investigation of six deaths last month caused by the human immunoglobulin manufactured by Jiangxi Boya Bio-Pharmaceutical. The drug maker, which obtained China's GMP authentication in 1998, has identified the drug batch in the incident. To date, 9,575 doses of the batch were sold, of which 3,192 had been used and the rest recalled. The company asserts that the drug's production process is in order and it has not received any notice from the authorities to stop production. It also stresses the stringent requirements for storing such a perishable product and is confident there is no issue of expiry. The Jiangxi province police are investigating whether any law-breaking activities happened in the distribution chain. (Click here for more - Chinese Language)

You may also be interested in...



Lethal Drug Manufacturer Resumes Production And Sales

Jiangxi Boya Bio-pharmaceutical, the manufacturer of the human immunoglobulin that caused six deaths last May (PharmAsia News, Jun. 9, 2008), has resumed its drug production and sales. Company inside sources confirmed that the product has been selling for some time, but only for wholesale business due to very small production output. An official at Jiangxi FDA revealed he has received information that Boya is not linked to the deaths but no formal report has been released. However, a State FDA spokesman stressed that the agency has not issued any such statement. (Click here for more - Chinese Language)

China’s SFDA Rapid Response To Biopharmaceutical-Triggered Deaths Seen As Progress By Industry Observers

BEIJING - In a case that closely parallels FDA's investigation of the drug heparin, China's State FDA is now examining a biopharmaceutical that triggered severe adverse reactions in seven Chinese patients, six of whom have died

FDA Slacking In NDI Notification Enforcement; COVID-19 'Is Not An Excuse’ – NPA

In a statement submitted to the Senate Finance Committee, Natural Products Association CEO Dan Fabricant suggests two ways of improving compliance with new dietary ingredient notification requirements at negligible expense to the US FDA.

UsernamePublicRestriction

Register

SC010771

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel