人體試驗之管制規範與審查程序——回顧與新進展【本期企劃】 試閱
Clinical Trials Regulation: Overview and Updates
近年我國積極發展生醫產業，相關管制規範也逐漸齊備。其中人體試驗受到嚴密管制的原因，是因為開發新藥所倚賴的動物試驗有相當大的侷限性，難以預測受試者將遭遇的風險；同時也是為了要確保試驗數據的正確、完整與相關性。對人體試驗的規範，包括試驗執行前、執行中與試驗結束後，由各個單位或團隊與政府，分別實施審查、監督、監測、安全性監測、查核等作為。這些規範在近年的進展，例如，國際藥品協和會促進各國規範趨於調和，目前新藥開發所要遵守的規範主要為該協和會與各國主管機關制定的細節性指引。另一個進展為我國立法對研究倫理審查會採許可制，並由主管機關定期查核。而面對日益常見的全球性或區域性公共衛生危機，新藥開發的規範需有緊急應變的彈性，例如藥品緊急使用的授權及分散式臨床試驗的措施等。
Taiwan has promoted the biomedical industry in recent years, and its related regulation has also been updated. Clinical trials are strictly regulated because animal testing, which new drug development relies on, has significant limitations. It makes it difficult to predict the risks that trial participants may face, thus necessitating proper protection of the participants. At the same time, it is essential to ensure the accuracy, completeness, and relevance of trial data to serve as the basis for drug approval reviews. The author reviewed the regulatory frameworks for clinical trials and their recent developments. For example, the efforts of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use have led to greater harmonization of regulations across countries. The regulations that modern trials must follow are primarily based on detailed guidelines issued by the Council and the respective regulatory authorities. Another development is that Taiwan has adopted a licensing system for research ethics review committees. Committees must be periodically licensed by the government before reviewing any research protocol. By the way, in light of the increasing global or regional public health crises, the regulation for new drug development must adapt, such as through emergency use authorizations and measures for decentralized clinical trials.
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