1. Which kind of drugs must be tested before imported?
(1). The biologic products prescribed by SDA. (2). The products sold into Chinese market for first time. (3). The other drugs prescribed by state department.

2. Which regulation must be complied as import drugs?
The import drugs must be inspected by SDA. The products can get the import licence only when they are approved to reach the quality standard and be safe and effective.
The drugs only can be imported from permitted port, and put on records at the local drug administration by importer. The custom will let the drugs pass base on «import drug customs form»issued by drug administration.
Without putting on records at local drug administration, the drug administration will warn the importer and charge them to correct it. If don't rectify it within the time limit, the register licence will be withdrawn.

3. Which notice should be paid attention to during the register.
3.1 demand for application information.
3.1.1 Application form
a. Filling the form based on the criterion, the blank must use "/" to be cancelled.
b. <import drug supplement form> should have 3 copies, with foreign company, producer and applicant's seals and signatures.
3.1.2 State documents
a. All of the drug certificates must accord with the normative format prescribed by WHO.
b. State documents specially which have been notarized mustn't be unsealed, unless with our permission, or the application will be cancelled.
3.1.3 Binding style
a. The application materials must be arranged with serial number.
b. The general and trade names of product, the names of producer and applicant, the application date and the current volume must be indicated by Chinese in the cover.
c. If applicating import biologic product, the applicant must offer 2 copies of whole information. 122296565
d. All the application materials must be written by SimplifiedChinese, or can't be accepted.