After a drug has been approved by the China Food and Drug Administration (CFDA), it can take another year and a half until the pharmaceutical product can actually be prescribed by a doctor. To shorten this process, some drug companies begin the price approval, bidding and hospital listing processes before receiving drug approval.
Drug pricing in China is a process that sets the price a hospital pays for the procurement of a drug product. The process of determining the price of an imported drug is different from that of setting prices for domestically manufactured drugs.
In China, the reimbursement price and sale price of a drug are not the same. The Chinese National Reimbursement Drug List (NRDL) is set by experts and representatives from several central government agencies and is updated every 4-5 years via a 4 step process. If a drug is not included on the NRDL, it can still be listed on the provincial drug reimbursement list. However, your company will need to lobby for inclusion on each province’s reimbursement list.
China also has an essential drug list (EDL) that is updated every 3-5 years. This list includes Western and traditional Chinese pharmaceuticals and covers treatments for more than 65% of China’s most common illnesses. Most healthcare centers and small public clinics are only allowed to purchase from the EDL. Larger hospitals are required to operate under a ratio of nonessential to essential drugs.
After a drug has provincial listing, it must then be listed by individual hospitals before it can be prescribed by a doctor. For more information on the processes of pharmaceutical listing, bidding, pricing and reimbursement, please see Pacific Bridge Medical’s recent article on Pharmaceutical Market Access in China.