ABSTRACT
This paper analyzes the registration regulations and guidelines of Traditional Chinese Medicine (TCM) products in South Africa, summarizes the registration path of TCM products in South Africa, analyzes the Common Technical Document (CTD) data required for registration from the aspects of quality control, safety and effectiveness, and discusses the registration strategy of TCM products in South Africa. This paper suggests that the strategies could include effective management and control of the registration risk of TCM and steady promotion of the products; TCM enterprises can first register low-risk TCM products, then open the South African TCM market, and promote the registration of high-risk TCM products after accumulating some experience; TCM enterprises need to have the awareness of promoting the inheritance, innovation and development of TCM, increase the investment in clinical trials of TCM products, and supplement the clinical effectiveness and safety data of TCM products; Strengthen the quality control of TCM and build an international brand of TCM.
ABSTRACT
Ghana attaches great importance to the use of traditional medicine. Over the years, Ghana has successively promulgated laws and policies on traditional medicine, which has laid a legal foundation for the research, registration and sales of its herbal products. This article briefly describes the regulation system of herbal and food supplements in Ghana, and sorts out the registration path of Traditional Chinese Medicine (TCM) products as herbal and food supplements. We also briefly analyze the registration information. We believe that TCM products can open the Ghanaian market as food supplements, so as to promote the registration of herbal medicines. TCM enterprise should controlling TCM registration risks, and strengthening the cooperation between the Chinese and Ghana governments. TCM enterprise can leveraging on the advantages of TCM theory and experience, and strengthening cooperation with Ghana's traditional medicine. This article provide advices for the registration and listing of TCM products in Ghana, expanding the market of TCM in Ghana which finally expands to West Africa and the entire African countries.
ABSTRACT
The existing regulations and systems of the Swedish Medical Products Agency (MPA) have clear provisions on the definition, classification and listed on the market procecure of pharmaceutical products, and the supervision strictly follows the EU standards. Traditional Chinese Medicine (TCM) products belong to the category of Swedish Herbal Medicine Products (HMP) or Traditional Herbal Medicine Products (THMP) and are under the supervision of Swedish Pharmaceutical Products Administration (MPA). This paper analyzes the classification, relevant regulations and registration procecures of TCM products in Sweden. It is suggests that TCM enterprises should fully understand the EU regulations and guidance regulations before listed on the market of TCM products. They should also clarify the product category, and provide sufficient and accurate evidence. In the application process, they should pay attention to strengthening communication with the drug administration units of Sweden.
ABSTRACT
As an important reference index to evaluate the quality of Chinese medicinal materials, the commodity specification and grade of traditional Chinese medicine has an effect on the medicinal material's price, can promote "high quality and high price" of the traditional Chinese medicine, prompt market transactions more convenient and standard, and has a great significance to the development of the whole traditional Chinese medicine industry. The formation of traditional Chinese medicine specifications and grades experienced a long historical development process. In order to provide the reference for modification of the product specifications and grades standards and management of traditional Chinese medicine products, the author consulted a large number of materia medica books and related references, sorted and analyzed the historical development process. The author divided the formation and development process into four stages, including germination stage before the Southern and Northern Dynasties, development stage of Tang and Song Dynasty, mature period of the Ming and Qing Dynasties and the inheritance development stage since the foundation of the People's Republic. The author believes that the clinical curative effect is the driving force to promote the development of commodity specifications and grades. In addition, the national pharmaceutical policy, international status, the level of science and technology also influence the development of commodity specifications and grades in some extents. Finally, the author provides three piece of suggestions for the modification of the product specifications and grades standards, according to the historical development rule.