Editorial:HK's Road to Set up Own Version of FDA
文章日期:2023年9月7日

【明報專訊】CURRENTLY, for a new drug to be registered and used in Hong Kong, the requirement of ''double authentication'' must be fulfilled, meaning that it must first obtain approval from two or more drug regulatory authorities in places such as the mainland, the US and Europe. The SAR government is considering revamping the mechanism so that a new drug can also be registered and used conditionally even if it only obtains approval from one regulatory authority. Given the high standards of Hong Kong's biomedical research, the city is capable of gatekeeping the licensing of drugs on its own. As long as local experts are engaged in the approval procedures, the shift from ''double authentication'' to ''single authentication'' will not be a problem. On the contrary, this could even serve as a foundation for the authorities to establish a drug regulatory authority in the long run, which would enable the city to approve drug registrations on its own.

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