Future development of global regulations of Chinese herbal products

Abstract

The regulatory issues for registration of herbal products are complicated among the countries and regions worldwide. The information summarised in the text is for reference only. Some regulations which are presented in this review are still in legislation process and may change in due course. Before taking any regulatory action, readers are advised to consult current official legislation and guidance and/or to seek appropriate professional advice. The lessons learnt from global regulation of TCM will provide valuable insights for regulation of other traditional medicine such as Ayurveda and Unani medicine, as well as other forms of indigenous medicine. The WHO is well placed to co-ordinate a consultation process with the aim of putting forward suggestions for harmonisation to key regulatory agencies.

Patent analysis: a look at the innovative nature of plant-based cosmetics

“…The relevant number of patent applications in Asiatic countries can be explained by the widespread use of natural products, where herbal-based therapies are essential part of the healthcare system, 10, 13,14 even with rigorous local regulations to ensure the quality, efficacy and safety of herbal products at international level. 15 Chinese legislation regulate the use of plants in cosmetics in a similar way to chemical drugs and biological products, requiring technical evaluations and clinical trials for new with anti-pigmentation, spot, melanin, sunscreens, slimming, breast care, hair growth, hair colors, perms, deodorant and depilatories cosmetics. 15,16 South Korea also requests high quality, safe and efficacy standards for registration of medicinal herbs and `functional` cosmetics as sunscreens, antiwrinkles and whitening formulations.…”

“…15 Chinese legislation regulate the use of plants in cosmetics in a similar way to chemical drugs and biological products, requiring technical evaluations and clinical trials for new with anti-pigmentation, spot, melanin, sunscreens, slimming, breast care, hair growth, hair colors, perms, deodorant and depilatories cosmetics. 15,16 South Korea also requests high quality, safe and efficacy standards for registration of medicinal herbs and `functional` cosmetics as sunscreens, antiwrinkles and whitening formulations. 15,16 A further analysis of the main patent head office's revealed that 1061 patent deposits were done by universities.…”

“…15,16 South Korea also requests high quality, safe and efficacy standards for registration of medicinal herbs and `functional` cosmetics as sunscreens, antiwrinkles and whitening formulations. 15,16 A further analysis of the main patent head office's revealed that 1061 patent deposits were done by universities. Among companies, Korean Amore Pacific was the most significant depositor (n= 428), followed by French Loreal (n=255) and Japanese Kao Corp (n=228).…”

Indigo Naturalis Ameliorates Oxazolone-Induced Dermatitis but Aggravates Colitis by Changing the Composition of Gut Microflora

“…Chinese herbal medicines have been widely used as folk remedies, and they are employed clinically in many countries including China, Japan, South Korea, the USA, Russia, and many European countries [34]. However, even though their effect is empirically obvious, inadequate scientific evidence from basic research often makes doctors skeptical and hesitant to use them.…”

Chinese phytotherapy to reduce stress, anxiety and improve quality of life: randomized controlled trial

“…The safety and efficacy of such practices and quality control have become important concerns. Thus, the preparations of Chinese formulas have followed the standard of Good Practice in Chinese Medicine (6) . The decoction Gan Mai Da Zao (GMDZ) is a Chinese formula widely used for depression in East Asia (7) and has been commonly recognized as a safe and effective prescription for the treatment of these mental disorders in China (8) .…”