Question:
请问在香港做临床试验,研究药物的管理需要遵从哪些法规?
Answer:
可以依据的香港本土法规有以下几种:
36B of the Pharmacy and Poison Regulations
Clinical Trial / Medicinal Test - Application Guidelines and Forms
Guidance for Pharmaceutical Industry - Adverse Drug Reaction Reporting Requirements (NOV 2017)
Import and Export of Pharmaceutical Products
如果该临床试验的结果用于中国递交,需要同时遵从中国NMPA GCP药品管理的相关规定。
https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html供参考。申办者需要具备获取相应法规的能力。