China Drug Registration

China is the second-largest drug market in the world. Registering drugs in China is more accessible today than ever. That does not mean it is easy or straightforward. Before attempting to do so, international drug companies should research the prevalence of the disease their specific drug treats in China to make sure it will be welcomed by the Chinese government and people. Does your drug offer real advantages over alternative existing treatments in China?

China’s National Medical Products Administration (NMPA) is the overarching government agency that approves drugs. Under the NMPA, the Center for Drug Evaluation (CDE) does the initial review.

Drugs are classified in China as – 1. Small molecule drugs, 2. Traditional Chinese Medicine, or 3.Therapeutic Biologics. Each class has sub-categories to further designate classification and registration paths.

To submit a drug application in China you need a Market Authorization Holder (MAH). For drugs made overseas, the Chinese MAH is usually the foreign drug manufacturer. For drugs made in China, the MAH is normally a domestic Chinese drug company.

Foreign drug companies can utilize 3 main strategies when doing clinical trials for China drug registration. First, you can do China trials simultaneously with your other global clinical trials. This is the fastest and cheapest way to proceed in China since you will be able to leverage overseas clinical data and reduce the number of patients in your local China clinical study. Second, foreign drug companies that have already completed their clinical trials in the West, can do an Asian multi-regional clinical study including about 50% of the patients from China. While this is more expensive than the first option above, more and more companies are choosing this strategy for their China/Asian drug development. Finally, as has been the main strategy in the past, foreign drug companies that have already completed their clinical trials in the West and received drug approval, can do a standalone Phase 3 study in China. This will be the most expensive way to proceed and delay the submittal of a registration application in China.

China has improved its clinical trial requirements in a number of ways over the last five years. First, it only takes 60 days to get a CTA approved. Second, imported drugs do not need to be approved overseas or complete Phase 2 studies, in advance of starting their China clinical trial. Third, more foreign clinical data is being accepted in China, especially if ethnic differences can be accounted for. There are also other changes that have made the clinical trial process easier for foreign drug companies.

Overall standard drug approval times have been shortened too. In addition, China is now implementing expedited drug approvals including – 1. Priority review, 2. Breakthrough therapeutic drug process, and 3. Expedited review.

Additional China drug approval programs have been implemented for certain parts of China including Hainan Island and the Greater Bay Area programs.

Unfortunately, despite quicker drug approval in China today, drug reimbursements have been dramatically cut. There are several programs to reduce drug prices including Volume Based Procurement, price reductions to get on the National Reimbursement Drug List and the implementation of the Designated Reimbursement Groups (DRG) and Diagnostic Intervention Packets (DIP) systems.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.