Regulatory IT Standards Issued by China's FDA
The China Food and Drug Administration (CFDA) announced 10 new information technology (IT) standards on 24 February that are designed to promote the interoperability of the country's food and drug regulatory information system.
The IT standards cover food and drug classification and coding; regulatory infrastructure information such as agency personnel, data sharing and exchange interface specifications; a common regulatory support platform; and a drug regulatory software development process specification.
There will be a gradual transition to the new standards based on actual experience gained during their implementation, CFDA said.