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Hong Kong Enhances Expedited Drug Licensing Process; Adopts Refuse-To-File Tool

 
• By Neena Brizmohun

Two announcements by the Pharmacy and Poisons Board have implications for drug companies looking to register their products in Hong Kong.

Hong Kong is working on making its drug registration procedures more efficient • Source: Shutterstock

Hong Kong has introduced more measures to incentivize companies to submit their drug marketing applications using the “1+” mechanism it launched last November to speed up the registration of products containing new chemical or biological entities for life-threatening or severely-debilitating diseases.

In addition, the country has implemented a new refuse-to-file (RTF) mechanism to “enhance its timeliness and efficiency” in managing the review of applications for the initial registration of pharmaceutical products/substances...

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