Based on the regulations of “LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS” and “Opinions of the State Council on the reform of evaluation and approval of the medical equipment and drug” etc, CFDA issues following policy to solve the problem of application overstock and speed up the evaluation and approval of drugs.

1.  Increase the standard of drug evaluation: for the drugs that has already in the market of international market and has not in the China market, it should be implemented bioequivalent study and be carried on the clinical trial following international general standard.

2.  Regulate the modified new drug: the applicants should submit the report that their new product is advanced to the original type. Or else, it will not be approved.

3.  Optimize the approval of clinical trial: The new clinical trial can be approved only once rather than divided into different phases. After finishing one phase, the applicant should submit the result and the plan for next phase and communicate with the approval staffs. Then they can go on next phase in case there is no safety issue.

From the Dec. 2015, the bioequivalent study of bio-similar drug will change into record-keeping system. The applicants should implement the bioequivalent study with the every aspects of original product based on the CFDA guideline.

4.  Evaluating the same type of product together.

5.  Withdrawing the application of unqualified product by the applicants is allowed.

6.   Strictly exam the drug effectiveness and safety.

7.  Speed up the evaluation and approval of drugs that are in emergency need:

(1)Novel drug of HIV prevention, malignant tumor, vital communicable disease, rare disease etc.

(2)Children drug

(3)Specific senior drug

(4)Listed in national vital novel drug research plan

(5)Emergent clinical need product made by advanced, novel technique and has obvious advantage

(6)The novel drug manufacture that transfer into the China

(7)Simultaneously carried on the application and got the approval of clinical trial in U.S., Europe area/Manufacturing in China, using the same line and already apply for into the market of U.S., Europe area and has passed the exam of local administrative agency.

(8) In emergent need of clinical use and in less than 3 years of patent expiration date/ In less than 1 year of patent expiration date.

8.  Severely punish the forge

9.  Publish the list of restrict category, to prevent the applicants apply for the drugs that are in over-production

10. Regulate the re-exam of drug registration

For more detail information, please visit CFDA Chinese version website: http://www.sda.gov.cn/WS01/CL0050/134665.html