Bloomberg BNA’s Patent, Trademark & Copyright Journal published an article on Aug. 12 featuring quotes from a client alert authored by life sciences partner Katherine Wang (Shanghai) that discusses the China FDA seeking feedback on drug registration rules. Additionally, an Danes Drug Daily Bulletin story published on Aug. 15 covers the development and cites a summary by Ropes & Gray.
Ms. Wang explains that the most concerning change for foreign pharmaceutical manufacturers is the removal of patent linkage. In China’s current Drug Registration Rules, any applicant must submit a drug application two years prior to the expiration date of any third-party patent in China, and the China FDA cannot approve an application before the patent expires. Under the revisions, any applicant can submit a marketing authorization application, regardless of the existence of third-party patents.
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