On October 16, 2020, China NMPA’s Center for Drug Evaluation (CDE) publishes key technical guidelines under which new drugs can be approved based on only foreign clinical trial data.  In other words, for certain types of new drugs, there is no longer the requirement to have the time-consuming and resource-intensive clinical trials completed in China.  To meet the criteria, these new drugs first need to be already approved in a foreign country.  When assessing if China clinical trial data are needed, under the guidelines, CDE will also take into consideration whether these new drugs provide significant clinical benefits and whether the current data demonstrate there are racial or ethnic differences that would affect the efficacy in the Chinese population. 

For readers of this blog, we are highlighting two scenarios for which the technical guidelines have discussed as examples when the China clinical data are exempt for a new drug application (NDA):

1. If the global clinical trial data already have the PK, and/or PD, efficacy, and safety data from the Chinese population, and the data demonstrate that the benefits for Chinese patients outweigh the risks; a NDA can be submitted with foreign clinical trial data only
2. If the global clinical trial data do not cover the Chinese population, yet there are sufficient investigation and analysis that demonstrate no significant racial or ethnic differences, a case-by-case analysis will be needed.  For drugs that are used to treat serious or life-threatening diseases, rare diseases, or diseases currently with no effective treatment, or the new drugs have significant clinical benefits compared with the existing treatment, the new drug may be approved based on foreign clinical trial data only.  However, postmarketing clinical trials should be conducted once the new drug is approved to manage the risk.

The technical guidelines also discuss situations when new indications or dosage forms are added and also clinical data requirements for generic drugs.

Of note to readers who are not familiar with CDE, the center under NMPA that is mostly in charge of all new drug approvals, in 2019 alone it has approved 58 NDAs (including new indications) submitted by international life science companies.  As businesses continue to develop new positioning strategies under the Covid-19 pandemic, they’ll also find new opportunities to leverage the sweeping regulatory and policy changes that continue to evolve in China.