探討製劑用原料藥變更與國際協和法規ICH Q12之對應   全文下載

Explore the Usage of ICH Q12 Tools to Master Change Management of API Suppliers of Medicinal Products

國際醫藥品法規協和會（The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH）於2019年正式公布「藥品生命週期管理指引-Q12」（通稱ICH Q12），提出多項對於化學製造管制資料（Chemistry, Manufacturing and Control, CMC）管理工具與風險評估策略。本文除分析藥品生命週期管理工具，另就法規面探討當製劑使用之原料藥變更時，對應ICH Q12許多項目之變更分級、確立條件（Established Conditions, ECs）、變更計畫書等，比較我國藥品查驗登記審查準則之要求與美國及歐盟各項原料藥相關變更要求異同，與分享對於上市後變更計畫書審查經驗，提供我國未來參考ICH Q12藥品生命週期模式，以科學與風險概念思考原料藥上市後變更管理方向。

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) completed the step 4 process of the “Guidelines for Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management-Q12” (commonly referred to as ICH Q12) and recommended for adoption to the regulatory bodies of ICH regions in November 2019. The Q12 Guideline is proposed to provide a framework to facilitate the management of post-approval changes in Chemistry, Manufacturing and Controls (CMC) in a more predictable and efficient manner across the product lifecycle. In this article we discussed the submission requirements and variations of the postapproval changes of the active pharmaceutical ingredients in pharmaceutical preparations in Taiwan and compared with the various categories of drug substance change variations in USA and EU. We also shared the experience in reviewing Post-Approval Change Management Protocol in Taiwan. This information allows us to understand where we should strengthen the regulatory requirements, using the tools suggested in the ICH Q12, and based on the science and risk assessment to evaluate post-approval change management of APIs.