中药在马来西亚具有较高的接受程度和广泛应用，同时马来西亚在药品注册和监管方面也具有比较完善的法规。中药常以天然药品或健康补充剂注册进入马来西亚市场，需要按照东盟共同技术档案（ACTD）格式撰写药品注册文件；根据产品注册声称的级别，马来西亚国家药品监管局（NPRA）会对产品进行完整审评或简化审评，并在最终审评通过后发放有效期为5年的产品注册编号（PRN）。结合注册实践，总结注册申报关键点：首先需确保申报中药处方成分适用性，然后提供符合马来西亚管理要求的产品工艺流程、规格信息及稳定性研究等药学研究资料，临床研究报告、Meta分析文献及与产品相关的国际认可的专论等有效性和安全性的支持依据，以及由马来西亚认可的机构出具的行政文件。中药在以天然药品项下的传统药身份注册、声称产品的传统用途之外，也可以具有治疗声称的天然药品注册，并以临床研究、学术论文、药典专论、医学典籍等多维证据材料支持产品的安全有效。中药的国际认可度日益提高，通过介绍中药产品在马来西亚的注册路径及相关经验，帮助更多中药产品在马来西亚注册获得批准，助力中药国际化进程。

Traditional Chinese medicines (TCMs) are well accepted and widely applied in Malaysia. There is a comprehensive and complete system of laws and regulations with respect to the registration and administration of drug in Malaysia including documents as the guidance of registration application. TCMs are often registered as natural products or health supplements in the Malaysia. The registration materials need to be prepared in accordance with the ASEAN Common Technical Dossier (ACTD) format, which will undergo full review or abridged review by National Pharmaceutical Regulatory Agency (NPRA). After evaluation approval, a Product Registration Number (PRN) valid for five years will be issued. Based on the practice of registration, the key points in product application are summarized: first, the ingredients of the TCM formula should be applicable, then the applicant should submit the documents of chemistry, manufacturing, and control such as product process, specification information and stability studies that meet the regulatory requirements of Malaysia, as well as the evidence of efficacy and safety, such as clinical study reports, Metaanalysis and internationally recognized monographs related to products, and administrative documents issued by institutions accredited in Malaysia. In addition to being registered as traditional medicines under the category of natural products which claims the traditional use of the product, TCMs may also be registered as natural products with therapeutic claim. Multiple evidences such as clinical research reports, academic papers, pharmacopoeia monographs and medical books can help support the safety and efficacy of the products. With the growing international recognition of TCMs, this article aims to help more TCM products to be registered and approved in Malaysia by introducing the registration process of TCM products in Malaysia and relevant experience, and help promote the internationalization of TCMs.

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