中藥在馬來西亞具有較高的接受程度和廣泛應(yīng)用，同時(shí)馬來西亞在藥品注冊(cè)和監(jiān)管方面也具有比較完善的法規(guī)。中藥常以天然藥品或健康補(bǔ)充劑注冊(cè)進(jìn)入馬來西亞市場(chǎng)，需要按照東盟共同技術(shù)檔案（ACTD）格式撰寫藥品注冊(cè)文件；根據(jù)產(chǎn)品注冊(cè)聲稱的級(jí)別，馬來西亞國家藥品監(jiān)管局（NPRA）會(huì)對(duì)產(chǎn)品進(jìn)行完整審評(píng)或簡(jiǎn)化審評(píng)，并在最終審評(píng)通過后發(fā)放有效期為5年的產(chǎn)品注冊(cè)編號(hào)（PRN）。結(jié)合注冊(cè)實(shí)踐，總結(jié)注冊(cè)申報(bào)關(guān)鍵點(diǎn)：首先需確保申報(bào)中藥處方成分適用性，然后提供符合馬來西亞管理要求的產(chǎn)品工藝流程、規(guī)格信息及穩(wěn)定性研究等藥學(xué)研究資料，臨床研究報(bào)告、Meta分析文獻(xiàn)及與產(chǎn)品相關(guān)的國際認(rèn)可的專論等有效性和安全性的支持依據(jù)，以及由馬來西亞認(rèn)可的機(jī)構(gòu)出具的行政文件。中藥在以天然藥品項(xiàng)下的傳統(tǒng)藥身份注冊(cè)、聲稱產(chǎn)品的傳統(tǒng)用途之外，也可以具有治療聲稱的天然藥品注冊(cè)，并以臨床研究、學(xué)術(shù)論文、藥典專論、醫(yī)學(xué)典籍等多維證據(jù)材料支持產(chǎn)品的安全有效。中藥的國際認(rèn)可度日益提高，通過介紹中藥產(chǎn)品在馬來西亞的注冊(cè)路徑及相關(guān)經(jīng)驗(yàn)，幫助更多中藥產(chǎn)品在馬來西亞注冊(cè)獲得批準(zhǔn)，助力中藥國際化進(jìn)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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