While obtaining approval for pharmaceuticals is a cumbersome process in almost any country, the procedure can seem exceptionally complex and sometimes unfathomable in China. Registration of a new imported drug can take anywhere from 8 months to 2 years or more. Furthermore, at each step of the process, the State Drug Administration (SDA) has the right to reject an application or require more documentation, further elongating the process. Reimbursement and other market access issues can make market entry even more difficult.
That said, the standard registration procedure for imported drugs is as follows. First, the applicant submits a completed Application Form and all required documents to the Department of Drug Registration (DDR) of the SDA. DDR takes between 20 and 30 days to inspect the application and documentation for errors, after which time (if acceptable) the DDR issues its Acceptance and Fee Payment Notice to the applicant. The application fee is paid at this time.
After this preliminary paperwork is completed, DDR asks the Drug Evaluation Division (DED) to begin its technical evaluation of the drug. First, DED completes an initial evaluation of the documentation. If the application is not rejected, it is forwarded to the next “Expert Evaluation Meeting. These meetings are held twice a year, normally in May and November, so depending on when an application reaches the DED, it can be anywhere from a few weeks to 6 months before the application is considered. After being considered at the Expert Evaluation Meeting, the DED issues a report on the drug to the DDR.
Assuming a drug has passed through to this stage, the next step is laboratory technical examination by the National Institute for the Control of Pharmaceutical & Biological Products, which takes approximately 40 to 100 days. If satisfactory, approval is issued for clinical trials, which are conducted by the applicant at DDR selected hospitals. After the trials (which generally last 2-3 months), DED submits an Integrated Evaluation Report to DDR, including both the results of the clinical trial and its own previous findings. From here, DDR submits its Evaluation Report to SDA, and, if acceptable, the SDA Director gives his approval. Finally, DDR issues a Registration Certificate to the applicant.
China represents an enormous potential market for a number of foreign pharmaceutical manufacturers, and as the economy continues to develop, opportunities will continue to grow. According to the U.S. Commercial Service, pharmaceutical sales have grown on average by 14% per year over the past 15 years, and some business analysts have predicted that China will become the world’s largest pharmaceutical market by 2020. While navigating the regulatory process can be quite difficult, the rewards can be worth it.