SFDA issues new drug tech transfer regs, GBI

Release Date: 2009-08-26

The State Food and Drug Administration (SFDA) issued the `Regulation on the Registration of Drug Technology Transfer' August 19 to standardize the registration process for drug technology transfers for the purpose of ensuring drug safety, according to the SFDA website.

Drug technology transfer is the process in which owners/inventors of a drug technology transfer the drug technology to drug manufacturers. The two major types of drug technology transfers are new drug technology transfers and drug manufacturing technology transfers.

A previous draft released in 2007 stated that new drug technology may be transferred to multiple drug manufacturers, but no related provision was included in this new document.

The document includes general provisions, criteria for applying for new drug technology transfers, criteria for drug manufacturing technology transfers, application and approval specifics for drug technology transfer applications, and other supplementary provisions.
Type: NORMAL
Company: GBI
Country: China
Url: http://www.gbipharma.com/cpbheadline.asp?newsid=2010490
 
This website requires Flash Player 9 or later. If you can not view this site you probably need to update your system with this plug-in for your browser.