Under the “1+” new drug approval mechanism, the approval process is simpler and faster than the traditional process. First, after an application is submitted, the Drug Office prioritises assigning a dedicated officer to follow it up, reducing the initial review time. Second, the mechanism allows the use of approval data from internationally authoritative bodies, reducing the need for repeated testing and review. Third, the approval period is generally shortened to within 6 months, compared with 12 months or more under the traditional process. In addition, interdepartmental coordination meetings are arranged during the approval process to resolve technical issues promptly and keep the process moving smoothly. The overall aim is to improve approval efficiency and speed up the launch of innovative medicines in Hong Kong.
HONG KONG DRUG LICENSING
How does the approval process under the “1+” new drug approval mechanism differ from the traditional process?
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