China taking actions for the fast approval of new drugs

28 September 2018

In an expert view, Maggie Chang, vice president, regulatory affairs, at China-based Hangzhou Tigermed Consulting, takes a look at what is now happening in China’s amended new drug approval system.

On September 5, China’s National Medical Products Administration (NMPA) announced the approval of the new drug application (NDA) for Soliris (eculizumab) Injection for the treatment of patients with PNH and aHUS in adults and children.

Both are rare diseases listed also by the Chinese government a few months ago. This product was developed by the USA’s Alexion Pharmaceuticals (Nasdaq: ALXN), while the CTA/NDA application in China was successfully handled by Tigermed.

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