Policy support and trend
In order to promote the research and development of innovative drugs in
mainland China, the Chinese government has implemented the new priority
review and approval procedure in 2015. Since 2016, the NMPA started
evaluating the quality and efficacy of generic drugs in order to further
reform and optimize drug innovation and improve the efficiency of drug
clinical trials. In 2018, the 60-day Investigational New Drug
Application System was officially adopted28-33. In
2020, the NMPA issued an announcement on three documents, including the
review procedures for breakthrough therapeutic drugs, the review and
approval procedures for the conditional approval of drug marketing
applications, and the priority review and approval procedures for drug
marketing authorization34.However, the results of our
study suggested that there is no significant change in the number of
trials regarding pregnancy drugs compared to the fast growing number of
anti-cancer drug trials. From 2009 to 2018, the annual growth rate of
anticancer drug trials in mainland China was 33%35.
The long-term follow-up assessment and enrollment are challenging
whereas the return and benefit are small, and there is a lack of
established laws and regulations to promote the development of drugs for
pregnant women. Prospective pregnancy registries to monitor drug-related
adverse reactions and follow-up throughout pregnancy are a feasible
approach. For example, the North American Anti-Epileptic Drug (NAAED)
Pregnancy Registry (http://www.aedpregnancyregistry.org/) and the
National Pregnancy Registry for Antidepressants (NPRAD
(https://womensmentalhealth.org/clinical and-research-programs/) are the
kind of website for registration and follow-up.In our study, we found
six similar clinical studies in which the registered drugs were
Levofloxacin, botulinus toxin, doxycycline, ribavirin, insulin and
levothyroxine. It may be an important potential study direction in the
future by establishing a collaborative research network for clinical
trials to collect obstetric clinical practice information through
electronic medical systems.