中藥新藥查驗登記法規之探討－以“腦得生”養腦散為例

Abstract

根據Market Research Engine報告指出，2025年全球植物藥市場將高達418億美元，年複合成長率為6%，加上新冠疫情衝擊，藥用植物的開發潛力不亞於西藥開發。植物藥在人體的使用經驗上已有數千年的歷史，且應用範圍廣泛、亦未有明顯的毒性與副作用，由於其生物活性與有效成分不全然能被定義、製程工藝上多源自於經驗法則，因此在臨床前的技術研究、藥物動力學等項目的審查標準訂定於法規上相對於化學藥品較寬鬆有彈性。台灣居於亞洲具有植物藥使用經驗的優勢、加以生技醫藥的技術發展純熟，勢必在全球植物藥的開發更有機會成為先驅。 然而自1998年衛福部公告中藥新藥查驗登記須知迄今已逾20年，衛福部核准上市的中藥新藥迄今僅有三個，本論文以腦得生生技（股）公司所研發的“腦得生”養腦散 BNG-1 Powder為例，透過質性訪談方式，經整理訪談內容後針對中藥新藥查驗登記法規提出建議，發現與結論如下：一、中醫藥司在西醫PI執行的臨床試驗與西醫適應症的管轄權問題。二、中醫藥司核定給中醫師開立的中藥許可證未有中藥主論的效能，而核定的西醫適應症藥品卻未能由西醫師使用。三、中藥新藥與植物新藥之差異如同中藥與西藥一樣，主要在於化學製造管制標準的不同，卻因此而將藥品分屬於不同的審查單位而導致上述之問題，故應有將中醫藥司與食品藥物管理署進行整合之必要。

According to the Market Research Engine report, the global botanical drug market will reach US$41.8 billion in 2025, with a compound annual growth rate of 6%. Coupled with the impact of the new crown epidemic, the development potential of medicinal plants is no less than that of western medicine. Botanical drugs have been used in the human body for thousands of years, and they have various applications and no obvious toxicity and side effects. Because their biological activities and active ingredients are not fully defined, the process technology is mostly derived from empirical rules. Therefore, the review standards for preclinical technical research, pharmacokinetics, and other projects are set in regulations looser and more flexible than chemical drugs. Taiwan is located in Asia and has the advantage of experience in the use of botanical medicine. With the technical development of biotechnology medicine, it bound to be more opportunities to become the pioneers in the development of global botanical medicines. However, it has been more than 20 years since the announcement of the new Chinese medicine inspection and registration instructions in 1998, and there are only three new Chinese medicines have been approved by the Ministry of Health and Welfare so far. Taking BNG-1 Powder as an example, through qualitative interviews, after arranging the interview content, it puts forward suggestions for the inspection and registration of new Chinese medicines. The findings and conclusions are as follows: 1. Does the Department of Chinese Medicine and Pharmacy have jurisdiction over the clinical trial by Modern medicine PI and Western medicine indication? 2. The TCM license issued by the Department of Chinese Medicine and Pharmacy for Chinese medicine physicians does not have the efficacy of the main theory of TCM, and the approved drugs for Western medicine indication cannot be used by Modern physicians. 3. The difference between new Chinese medicines and new botanical medicines, like Chinese medicines and Modern medicines, is mainly due to the difference in the control standards for chemical manufacturing and control. However, the above-mentioned problems are caused by the division of medicines into different review units. The need for drug administration between the Department of Chinese Medicine and Pharmacy and TFDA to integrate.