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News!
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Traditional Chinese Medicines Worldwide Regulations on TCMs A. PRC State Drug Administration All Chinese medicines (CMs) are regarded as drugs and governed by the State Drug Administration. Those CMs, which do not meet the stringent regulations of drugs, cannot make claims of efficacy and may choose the category of functional food. CMs drugs can be set into five categories depending on the formulations, compositions and channels of administrations:
B. HKSAR Department of Health 1. Any drugs that contain raw CMs traditionally used in the Chinese communities are regarded as Chinese medicines and regulated as such by the medical authority. 2. All CMs must be proved safe, efficacious and stable before marketed in the public. 3. CMs are categorized according to the time of marketing:
4. There are sub-categories depending on the use as drugs or nutritional supplements. Proof of safety and stability must be submitted in all applications for registration, whereas clinical study documentation is required for CMs drugs. 5. These documents must be submitted to the Department of Health for registration according to a transition scheme:
6. The safety documents must include basic safety data, including freedom of contaminants, such as heavy metals, pesticides, steroids, microbes, etc. 7. The stability of all CMs must be labeled on the package/container. C. US Food and Drug Administration 1. Drugs can make claims of efficacy and marketed as such in all pharmacy in the hospitals and drug stores after such product has passed the stringent evaluation of all phases of clinical trials (I, II & III). So far, none of the CMs has acquired this status yet, even some had come to the threshold of being permitted to undergo such study. 2. Botanical Drugs are those natural botanical products being used to alleviate medical ailment for a number of years with good track record of safety outside the USA. The pre-clinical trial may be waived if such product can show sufficient proof of safe use in the markets. Once proven as such, it can marketed in the public as over-the-counter (OTC) drugs. The Tiger Balm is the first CMs ever to receive such recognition. 3. Dietary Supplements are mainly edible products to enhance the general well being of human kind. They can be the crude extract and single-ingredient extract of botanicals in simple or complex formulation, or trace elements, or vitamins, or a mixture of some of these make-ups. It has to provide safety documents in its human use and up to the FDA to prove so. Within 30 days of its submission of its intention to market in the States to the FDA, it can be put to the market if no reply is heard from this health authority. --- By Dr. Brad Lau Go to: How CCPP Helps the Modernization of TCMs Useful Links to Regulations on TCMs
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