PharmAsia News: Shanghai FDA Withdraws GMP Certificates, Suspends Production Of Drug Makers As Part Of “Five Links” Program

SHANGAHI - Shanghai FDA withdrew two GMP certificates and suspended the production of two companies in an effort to enhance compliance by drug and device manufacturers to the “five links” program, the Shanghai government announced Dec. 10.

Shanghai FDA launched the five links program in August after the state council announced it would take measures to enhance drug safety.

Shanghai FDA Spokesman Du Bing told PharmAsia News that the five links are: drug research and development, production, distribution, usage and advertising.

“The plans to further enhance drug safety through the five links for next year are under discussion and we will issue the plan at the end of this month or early next month,” said Du.

There are 236 drug makers and 51 drug research organizations in Shanghai; the GMP certificates of 191 of 236 drug makers were past their expiration dates by the end of 2005, according to Du.

As a result, all 191 drug makers were inspected in September, 178 of which will be continuously tracked and will be subject to further special inspections.

“FDA will rate these companies according to the special inspections and inspect them with a frequency according to the rating,” said Du.

Shanghai FDA also sent 11 supervisors to local drug makers, covering all producers of blood products, vaccines, special drugs, narcotics and psychotropic drugs in China.

During the inspections, the GMP certificates for two companies were cancelled and two companies were ordered to suspend production.

For research and development compliance, Shanghai FDA verified 3,740 drug approval numbers, only one of which, Ruoyi antihypertensive tablets, failed to pass the check.

“The producer of Ruoyi antihypertensive tablets then cancelled the drug approval on its own,” said Du.

In addition, Shanghai FDA sent six groups of inspectors to conduct on-the-spot audits of 466 drugs during their drug registration, according to Du.

In the distribution area, 40 drug distribution companies, 328 drug retail companies and 555 medical device companies were ordered to correct their conduct.

Shanghai FDA also cancelled the licenses of 116 retail drug stores and 667 device companies, Du said.

In usage inspections, Shanghai FDA focused on 95 private hospitals and inspected their purchasing processes, records and storage conditions.

The agency also increased the rate of drug sampling inspections with high-risk drugs such as injectables.

Finally, Shanghai FDA and the Shanghai Administration of Industry and Commerce inspected 420 companies for illegal advertising, which included 216 local retail drug stores, 42 hospitals, 58 health supplement product stores, 30 shopping malls and 74 supermarkets.

“Eight hundred and forty four illegal advertising issues were found during the inspection and the municipal AIC issued notices to expose these illegal advertisements to the public,” said Du.

– Dai Jialing (pharmasia@elsevier.com)