Taiwan Radiopharmaceutical Development: A Step-by-Step Overview for Clinical Trials

Li-Yu Chen, MS,Ya-Ting Huang, RN, NP, PhD, Ya-Yao Huang, PhD,

Published by 2022 Annals of Nuclear Medicine and Molecular Imaging，35(4)，159-169。

Studies on precision medicine and novel therapeutics for various types of cancer have surged. Advancements in these technologies have revealed the importance of radiopharmaceuticals. The United States and Europe have established comprehensive regulatory frameworks to promote the development of radiopharmaceuticals. In Taiwan, efforts have been made to formulate relevant regulations, particularly regulations of investigational new drugs (INDs). For instance, ＂Clinical Trial Benchmarks for Radiopharmaceuticals in Nuclear Medicine＂ (revised in 2021) and the proposed ＂Guidelines for Clinical Development Strategies of Diagnostic Contrast Agents＂ are important guidelines in the development of radiopharmaceuticals for non-clinical toxicology drug testing and the design and evaluation of clinical trials. Since 2017, increasing numbers of radiopharmaceutical studies and clinical trials have been conducted, and new diagnostic radiopharmaceuticals have been introduced in Taiwan. However, researchers at academic institutions often regard clinical trials of drugs, especially investigator-initiated trials, as perilous undertakings because of limited labor and resources and complicated clinical trial applications. Therefore, herein we report the current status of radiopharmaceutical development both in Taiwan and the rest of the world and present a simplified application procedure for radiopharmaceutical clinical trials based on our experience, with three stages and eight steps, to improve the understanding of IND applications among medical researchers, thereby promoting the development of new radiopharmaceuticals in Taiwan.

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