Objective: To provide a reference for improving the regulatory system of radiopharmaceutical in China. Methods: The particularities, regulatory elements and pain points of all aspects of whole life cycle of radiopharmaceuticals were sorted out,and suggestions were put forward by comparing the domestic and foreign regulatory literatures and combining with comprehensively analysis of expert discussions and interviews as well as questionnaire inquiries. Results and Conclusion: Based on the particularity of radiopharmaceuticals, suggestions were put forward on improving the radiopharmaceutical regulatory system in China, including general suggestions on legal and regulatory frameworks, and the regulatory suggestions at each aspect of the whole life cycle such as research and development, registration, production, circulation, use and environmental impact assessment.
Ma Weiwei
,
Zhang Ye
,
Liu Shuang
,
Wu Xiaoyan
,
Qu Qiaoling
,
Li Tuo
,
Xu Xing
,
Lü Xinhuan
,
Lü Xin
,
Bai Juan
,
Yang Jianhong
,
Zhang Wei
. Research Ⅳ on China’s Radiopharmaceutical Regulatory System：Suggestions on Improving China’s Radiopharmaceutical Regulatory System[J]. Chinese Pharmaceutical Affairs, 2025
, 39(1)
: 34
-44
.
DOI: 10.16153/j.1002-7777.2024-11-0055
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