The State Food and Drug Administration (SFDA) governs the regulation of vaccines in China. Sinovac takes the following steps to gain approval from the SFDA to sell its vaccines in China:



Pre-Clinical Trials:
The process involves in-vitro laboratory and in-vivo animal testing. It also includes a study on the echnology process, and establishes quality control and test evaluation standards for the safety, efficacy, and stability of the vaccine throughout animal trial testing.

Clinical Trial Approval:
After a formal review and evaluation of per-clinical results, the SFDA makes a determination to approve or disapprove commencement of human clinical trials using the product. After three phases of human clinical trial of a new drug, the independently prepared results and three lots of product samples are ubmitted to the SFDA at the same time the Company applies for a new drug certificate and production license.

New Drug Certificate & Production License:
The new drug certificate grants approval for the research and development process of a drug that has never been approved for production or sale in China. The production license is approval for vaccine production. After completing three phases of clinical trial and passing the evaluation by a professional delegation, the SFDA will issue a new drug certificated to the manufacturer. This grants the filing Company intellectual property rights to this drug. Chinese administrative protection for the new roprietary drug starts from the date of the issuance of the new drug certificate.

GMP certificate:
The GMP certificate is for the monitoring of drug manufacturers. After receiving a new drug certificate and production license, the company submits an application for GMP (Good Manufacturing Protocol) ertification. This provides approval for the equipment and control of the manufacturing workshop of the particular drug.

A new drug is only officially approved for sale in the Chinese market once these steps have been completed.