Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Jill Roberts
Another way to know what’s too old to eat
Patricia Santos-Serrao
Four pharma quality trends
Del Williams
Preventing damage caused by large, suspended particles
Kari Miller
An effective strategy requires recruiting qualified personnel familiar with the process and technology

More Features

FDA Compliance News
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains

More News

Calypte Biomedical Corp.

FDA Compliance

Chinese State FDA Completes Technical Review of Oral HIV Test Application

Published: Tuesday, February 26, 2008 - 23:00

(Calypte Biomedical Corp: Portland, Oregon) -- Calypte Biomedical Corp., a developer, manufacturer and marketer of HIV diagnostic tests, recently announced that the Chinese State Food and Drug Administration (SFDA)—the equivalent of the U.S. FDA—has notified Calypte’s Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co. Ltd., that the technical review of its Aware HIV-1/2 OMT rapid oral test product application has been completed. Pending the SFDA’s review of conformity to product standard documents and labeling to applicable regulations, the application will progress to the concluding administrative approval.

“This is a major milestone in a long and difficult approval process,” says Roger I. Gale, Calypte’s president and CEO, “We are extremely pleased that the SFDA has determined that our scientific data has met their criteria, and that we are now moving into the final phase of the registration process. We believe that in meeting the technical standards established by the SFDA, we have demonstrated to them the high quality of our product.”

Calypte operates in China through Beijing Marr, a joint venture between Calypte and the Marr Group established to manufacture Calypte’s Aware line of rapid HIV tests, including the Aware HIV-1/2 OMT product for the Chinese and international markets.

SFDA guidelines for registration and technical review are strenuous. “The technical review is considered the most challenging and lengthy portion of the SFDA review process, and is the penultimate milestone in the approval process,” says Dr. Ronald W. Mink, Calypte’s chief science officer. “We are absolutely delighted that we have overcome what is arguably the highest hurdle in the approval process, and are ready to move into the final administrative stage.”

For more information, visit http://eng.sfda.gov.cn/cmsweb/webportal/W43879541/A64007096.html


About The Author

Calypte Biomedical Corp.’s default image

Calypte Biomedical Corp.