| 摘要: | 隨著人類財富累積，生活改善，使得世界各國對醫藥養生更為重視，而因植物成份具有回歸自然概念，故以植物成份作為養生醫療蔚為風尚。積極規範與發展植物藥已是世界的趨勢，中藥為我國醫藥文化重要資源，歷經數千年而不衰，愈具開發價值。目前世界各國對植物性成份的醫藥與養生功能較以往更為重視，對藥性溫和之中藥與天然物的需求更為增加，又民眾對於傳統中藥向來都有「藥食同源」的觀念，部份藥材常被當作一般食品烹調食用，此觀念也促進健康食品、功能食品及改善食品的風行。然而，中醫藥典籍例如：『本草綱目』的制訂乃以藥為前提，而不是以食品為前提，因此若要將中藥材當成食品，仍應提出安全報告與科學論證較易獲得認同，也較能保障民眾安全。先前的研究計畫已調查美國、英國、歐盟、紐西蘭、澳洲、日本與中華人民共和國有關可供食品使用之中藥材之相關規定，發現日本及中華人民共和國之衛生單位訂有中藥材可供食品使用之品項。我們也已依據國外對於新藥，植物性新藥，新穎性食品，健康食品及食品添加物之安全性評估原則，訂定「中藥材同時供食品使用之安全性評估基準」，並諮詢中醫藥、食品、藥理學、毒理學各界專家意見。對於神農本草經所定義之上品藥材，比較各國衛生單位對於該中藥材是否可供食用之管理情形，選出適合做為可供民眾食用之藥材。 於執行上述計畫過程中，我們發現中藥材除供食品使用外，若以健康食品的形式服用，更能達到控制劑量的效果，也能以「product by product」審查，其安全性保障更為明確；另若有適當的效能宣稱，對民眾而言也是有用的使用指引。。 本計劃將進行以下工作：一、 調查美國、加拿大、歐盟、日本、中華人民共和國可供健康食品或保健食品使用之中藥材品項及其宣稱之效用，及各國申請上市所需檢附之有效性及安全性資料。二、 由上述結果，建議我國供健康食品使用之中藥材品項。三、 由上述結果，建議我國供健康食品使用之中藥材之宣稱之效用之方式與分類。四、 依據國外對於新藥研發、新穎性食品、植物性新藥與健康食品之安全性評估辦法，訂定中藥材同時供健康食品使用之安全性評估原則。五、 綜合上述各點訂定「中藥材同時供健康食品使用之基準」，並諮詢中醫藥、食品、藥理學與毒理學各界專家意見。本計畫成果可為中藥材作為低度療效宣稱政策制定之參考。
People in the world have focused on how to keep health because of the wealth accumulation and life improvement. Herbs have the natural concept, so that using herbs to keep health is quite popular. Nowadays, every country dedicates to study and develop herbal medicines. Traditional Chinese Medicine (TCM) is a system of healing that has long been utilized in the Chinese culture and is of great values in this regard. In order to promote the safe use of Traditional Chinese Medicine (TCM), and as suggested by the 23rd Science & Technology Advisory Board Meetings and Strategic Review Board (SRB) Meeting, Taiwan’s Department of Health is considering the possibility of allowing some TCMs to be used as foods. These will be gradually phased into use. Our previous study investigated how international regulatory authorities regulate TCMs intended to be used as foods. We also analyze whether the most frequently used TCMs are suitable to be used as foods and we attempt to establish guidances for safety assessments. We have completed the following work. (1) We investigated guidances published by regulatory authorities in the U.S, U.K., E.U., Japan and Mainland China, that allow TCMs to be used as foods. Lists have been released by both the Japanese and Mainland Chinese authorities regarding which TCM items may be used as foods. (2) With reference to safety assessment guidances for new drugs, botanical new drugs, novel foods, health foods and food additives, we have established the “Safety assessment guidance for TCMs to be used as foods”. We have also consulted leading experts in Chinese Medicine, Food Science, Pharmacology and Toxicology. (3) We collected toxicological data and records concerning food use from literature for high-grade TCMs in the Materia Medica of Deity of Agriculture. With reference to other regulatory authorities’ policies, we list the TCM items deemed appropriate for food use. We also found that if TCMs could be used as health foods, the dosage actually being taken could be control better. The regulatory authority could review these products on a product by product basis. All these can provide more safety for the use of TCMs. Besides, appropriate health claim for these TCMs products also instruct people to use them properly. The present study aims to complete the following work: 1. We will investigate guidances published by regulatory authorities in the U.S, Canada, E.U., Japan and Mainland China, that allow TCMs to be used as dietary supplements. We will search lists which are released by authorities regarding which TCM items may be used as dietary supplements. We will also investigate how the health claims of these products are made and the data requirement to support them. 2. We will suggest a list regarding which TCM items may be used as health foods in our countries. 3. We will suggest a strategy regarding how to make the health claims of TCM health foods. 4. We will make a guidance regarding safety assessment for these products with reference to the guidelines of other countries. 5. We will integrate the above points into a “Guidance for TCMs to be used as health foods” |
