Biologics Section, Centre of Product and Cosmetic Evaluation, National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Selangor, Malaysia.
National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia, Selangor, Malaysia.
Adv Exp Med Biol. 2023;1430:181-195. doi: 10.1007/978-3-031-34567-8_10.
The National Pharmaceutical Regulatory Agency (NPRA) is the agency responsible for the registration of pharmaceutical, natural, and health supplement products and notification of cosmetic products that are marketed in Malaysia. The implementation of regulatory oversight of the different types of product was in a progressive manner, with the latest addition to be regulated being the cell and gene therapy products (CGTPs), beginning January 1, 2021. CGTP can be classified as low risk (that does not require registration) or high risk (that needs to be registered). Generally, the regulation of high-risk CGTP is similar to other biological products. This chapter describes the chronology of the CGTP framework, classification of CGTP, how CGTPs fit into the current registration pathways and registration procedure, dossier requirements, and what is the current status and future direction of CGTP in Malaysia.
国家药品监管局（NPRA）是负责药品、天然药物和保健品注册以及在马来西亚上市的化妆品通知的机构。对不同类型产品的监管监督是逐步实施的，最新纳入监管的是细胞和基因治疗产品（CGTP），从 2021 年 1 月 1 日开始。CGTP 可分为低风险（无需注册）或高风险（需要注册）。一般来说，高风险 CGTP 的监管与其他生物制品相似。本章描述了 CGTP 框架的时间顺序、CGTP 的分类、CGTP 如何适应当前的注册途径和注册程序、档案要求，以及 CGTP 在马来西亚的现状和未来方向。
