By Alan Zhou 周磊 / Sophie Han 韩素锋
As a continuing effort to reform China’s drug system, the China Food and Drug Administration ("CFDA") published the Decision on Adjusting Items concerning the Administration of Imported Drug Registration (Draft for Comments) (the "Draft") [1] on its website on March 17, 2017 for public comments by April 20, 2017.
The Draft, with only four provisions though, has drawn wide attention and extensive discussion among the pharmaceutical industry since issued. Below we summarized the key points of the Draft for your reference:
1. Cancellation of the previous requirement that the drug should be registered abroad or have entered its Phase II or III clinical trial before its International Multi-Center Clinical Trial ("IMCCT") is conducted in China (exclusive of vaccines);
2. The application of market access registration of an imported drug (Imported Drug License) can be submitted to CFDA as soon as its IMCCT is completed in China;
3. Applying for the China market assess permit for the imported invocative chemical and biological drugs is no longer required to obtain the market authorization abroad before such application in China;
4. Any accepted application before the publicity of the Decision, further requesting the exemption of an imported drug clinical trial and submitting the IMCCT data, with other requirements fulfilled, can be granted an approval.
As far as we can see in the Draft, foreign pharmaceutical manufacturers are encouraged to conduct IMCCTs and early-stage clinical trials in China, and the thresholds are lowered for drug import into China market. It is believed that with the approval of the Draft, certain changes shall be made to the pharmaceutical industry in China.
Preliminary Observations to Multinational Pharmaceutical Companies (MNCs)
1) Shortened Timeline for Imported Drug Registration
Over a long period of time, the entry of imported drugs into China is several years or even decades later than their marketing overseas due to the requirement of obtaining the overseas market permits and those extra rounds of clinical trials conducted in China. By canceling certain requirements as mentioned above, MNCs would be able to initiate the application process for the new import drug permit in China at a much earlier date compared with the current existing practice. If an IMCCT of the drug is conducted in the territory of China, theoretically, MNCs may even avoid conducting phase II trial and/or the imported drug clinical trial in China in the application for new import drug permit as provided in the Draft. Ideally, the launch of a new drug in China could be at the same time as it is overseas.
2) Prolonged Patent Protected Period
By the earlier launch of the product as above mentioned, it is very likely that the MNCs have longer period of time to sell their imported drugs in the Chinese market before the patent expiry of such drugs.
Before we try to understand the Draft, we need to have a full picture of CFDA’s recent drug reform where the quality issue is prioritized and then price control, whose ultimate goal is to benefit Chinese patients. In general, MNCs’ drugs are of high quality standard while local players’ may be not; and thus, CFDA’s reform brings challenges to the MNCs. It is implied that MNCs may be the direct and prime beneficiary in the Draft; however, whether the approval of the Draft will definitely bring a fundamental change to the market of imported drugs remains uncertain. Nevertheless, the shortened timeline for registration of imported drugs, which makes a huge difference, does mean a considerable extra revenue to MNCs. It is advisable that MNCs closely monitor any subsequent development of the Draft so as to smoothly adapt to the new changes of imported drug registration.
【1】总局公开征求《国家食品药品监督管理总局关于调整进口药品注册管理有关事项的决定（征求意见稿）》意见的通知, available at http://www.sda.gov.cn/WS01/CL0778/170840.html.
