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Thanks. China FDA approval process...
The Chinese SFDA approval process is very similar to U.S. FDA. Why? Because Chinese government has adopted many U.S. laws and regulations like many other development countries. If you apply new drugs in China, you may have to go through the same processes like here such as three phases and many years testing/waiting. Since Calypte HIV testing tool is not a drug so the process is much shorter.
First step: Calypte must go through Beijing Food/drug agency (Local agency) since Marr is registered in Beijing district. (All applicants must submit their applications to local province FDA agency first. Ex: if a company is located in ShangHai, the company must submit NDA to ShangHai FDA first).
Second step: if the Beijing (local) FDA agency approves the application, then they submit the files to SFDA on behalf of the applicant.. (the duty of local FDA agency is to ensure the application is complete, the company is genuine, the fee is paid, and other minor things. This will help SFDA to save manpower and time).
Third step: after receiving the package from local FDA. SFDA sends the application to CDE for evaluation. (CDE much likes U.S. FDA review panel; CDE...Center for drug Evaluation).
Forth step: CDE reviews and evaluates the application (here is Aware OMT). If CDE OKs (or not OKs) the application, the recommendatin will be made and the package will be send back to SFDA for approval (or disapproval).
Fifth step: SFDA takes final look and makes final decision (approval or disapproval) based on CDE recomm.
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