To implement the relevant spirit of executive meeting of the State Council of China and accelerate the entry of clinically imperative new drugs marketed overseas into China, the National Medical Products Administration (NMPA) and National Health Commission of China organized relevant experts on Mar. 28, 2019 to conduct research and demonstration and select the second batch of clinically imperative overseas new drugs.

The NMPA has further optimized the review and approval of clinically imperative overseas new drugs since 2018, and the first batch of innovative drugs including Gardasil 9, Opdivo, Keytruda, and Soliris (eculizumab), etc. have been accelerated to enter China. The second batch of clinically imperative overseas new drugs released by the NMPA will be focused on in this article, and the development progress of drugs among the first batch in China will be briefly updated.
I. Help from policies: Global innovative drugs speed up to enter China
The NMPA has introduced many important review and approval policies in recent years, such as priority review, acceptance of overseas clinical trial data of pharmaceutical products, optimization of review procedures for imported innovative drugs, and clinical trial implied permission, which provide unprecedented opportunities for global innovative drugs to speed up to enter China, wherein, rare disease drugs have been benefited more as opportunities for them to be marketed in China are rare.
The second batch of clinically imperative overseas new drugs this time has a distinct characteristic:
The proportion of rare disease drugs accounts for a half: 15 drugs in the list of second batch are rare disease drugs, such as Fabrazyme (Agalsidase Beta) for β-galactosidase A deficiency; furthermore, many drugs have been included in the list owing to "therapeutic advantages over marketed products", such as the HCV drug Maviret and HIV drug Biktarvy.
There are many noteworthy points in the second batch of clinically imperative overseas new drugs, specifically:
A. Many drugs have been marketed in China and entered the list upon single indication
For example, according to the information queried, the pharmaceutical products in the list of second batch that have been marketed in China and entered upon single indication include: insulin detemir for Noonan syndrome, ustekinumab for Crohn’s disease, adalimumab for uveitis, and ciclosporin for the new indication of keratoconjunctivitis, which is developed by Santen.
And bosentan dispersible tablets of Actelion has also entered the list. According to the information queried, bosentan tablets has been marketed in China and entered the list upon the new dosage form.
Those drugs, after they enter the second batch, will be further accelerated approval for subsequent expansion of particular new indications or new dosage forms.










(All Rights Reserved)