新加坡细胞、组织和基因治疗产品的监管监督。

Regulatory Oversight of Cell, Tissue, and Gene Therapy Products in Singapore.

机构信息

Advanced Therapy Products Branch, Medicinal Products Pre-Market Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore.

出版信息

Adv Exp Med Biol. 2023;1430:197-210. doi: 10.1007/978-3-031-34567-8_11.

DOI:10.1007/978-3-031-34567-8_11

PMID:37526849

Abstract

The Health Sciences Authority of Singapore has implemented a fit-for-purpose regulatory framework for Cell, Tissue, and Gene Therapy Products (CTGTPs) on 1 March 2021. A total of 11 pieces of subsidiary legislation for CTGTP are gazetted under the Health Products Act as Health Products (CTGTP) Regulations 2021. The CTGTPs are stratified into lower-risk Class 1 CTGTP or moderate- to higher-risk Class 2 CTGTP based on their degree of manipulation, intended use, and if they are combined or used with therapeutic products or medical devices. The regulatory controls are calibrated to the different risk profiles of the products. This risk-based regulatory approach aims to facilitate successful product development and registration in Singapore for innovative CTGTP with a least burdensome regulatory framework while ensuring reasonable safeguards on the safety, quality, and efficacy of the products. This chapter describes the regulatory oversight of CTGTP in Singapore.

摘要

2021 年 3 月 1 日，新加坡卫生科学局（HSA）为细胞、组织和基因治疗产品（CTGTP）实施了一个有针对性的监管框架。根据《药品法》，共有 11 项 CTGTP 的附属法规被颁布为 2021 年《药品（CTGTP）法规》。根据其操作程度、预期用途以及是否与治疗产品或医疗器械结合或使用，CTGTP 被划分为低风险的 1 类 CTGTP 或中高风险的 2 类 CTGTP。监管控制措施根据产品的不同风险特征进行调整。这种基于风险的监管方法旨在通过最具负担性的监管框架，促进具有创新性的 CTGTP 在新加坡的成功开发和注册，同时确保产品的安全性、质量和疗效得到合理保障。本章描述了新加坡对 CTGTP 的监管监督。