Monday, May 19, 2008

Chinese SFDA crackdown to get house in order

The Chinese State Food and Drug Administration (SFDA) has revealed plans to tighten the drug registration review process as it attempts to improve standards in the nation.

At the regulatory body's monthly press conference a SFDA spokesman spelt out the policy which will only allow drug companies one opportunity to file their application documents.

By adopting a hard line stance the SFDA is sending out a strong message to its critics both at home and abroad who have cast aspersions on the integrity of the registration process.

SFDA spokesperson Yan Jiangying said: "In cases where a company's application does not satisfactorily prove the safety and efficacy of its product, the SFDA will no longer ask for further information, unlike in the past, but will simply reject the application outright."

This shift in policy is the result of an in-depth review of documents submitted to the SFDA between January and April this year to verify all information in the applications through pharmacological, toxicological and clinical trial analysis.

From this the SFDA discovered that some of the drug application documents were quite similar, which it believes is likely to signify that the company has fabricated the data.

link to full article

1 comment:

Chin Youhan said...

The China Medical Device Regulations are on their way in China has Updates on Developments for Medical Devices LLP, and a new release is expected on June 1st 2014.The medical devices needs and demands vary with geographical regions, hospital levels, number of patients and source of funding.