CFDA issues guidance on drug review and approval transparency

With hopes to improve transparency, China FDA issued draft guidance on the public disclosure of information related to its review and approval of drug applications.

The guidelines say the agency is responsible for disclosing information regarding an application's acceptance, the review and approval process and result of the review through a public drug trial center portal. The drug trial center is to create a review system to decide which information is to be made public such that details, including trade or technical information, remain confidential...