China announced earlier this month that it will begin accepting clinical trial data from other countries, Outsourcing-Pharma.com reports. The new guideline, issued by the General Office of the Communisty Party of China Central Committee and the General Office of the...
China’s Food and Drug Administration (CFDA) set a goal to push drugs to clinics faster. How will they accomplish this goal? Recent policy proposals suggest CFDA are looking at the US Food and Drug Administration (FDA) for answers. Imitation is the greatest form of...
In July, China’s Food and Drug Administration (CFDA) allowed self-inspections to occur for imported and local drugs. Although CFDA is allowing self-inspections for drugs, it will also be conducting random on-site inspections upon the reports that companies give them....
With China’s economy continuing to develop many people in their population will begin to receive advanced healthcare for the first time. Now it’s time to look to see how China can learn from the healthcare insurance systems from around the world and what opportunities...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
