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Научни трудове на Съюза на учените в България-Пловдив. Серия Г. Медицина, фармация и дентална медицина т. XXII. ISSN 1311-9427 (Print), ISSN 2534-9392 (On-line). 2017. Scientific works of the Union of Scientists in Bulgaria-Plovdiv, series G. Medicine, Pharmacy and Dental medicine, Vol.XXII. ISSN 13119427 (Print), ISSN 2534-9392 (On-line). 2018.
РЕГУЛАЦИЯ НА ТРАДИЦИОННИ КИТАЙСКИ ЛЕКАРСТВА
Лилия Караманчева1, Валентина Петкова2, Калина АндреевскаЗ,
Даниела ГрековаЗ lQueisser Р11агта,България, мениджър, 2Медицински Университет-София, Фармацевтичен факултет, ЗМедицински Университет-Пловдив, Фармацевтичен факултет
REGULATION OF TRADITIONAL CHINESE MEDICINES
Lilia Karamancheval, Valentina Petkova2,Kalina Andreevska3,
Daniela Grekova3
1 Queisser Pharma - Bulgaria, Country manager,2Medical Univers ity of Sofia, Faculty of Pharmacy, Department of Social Pharmacy 3Medical Univers ity of Plov div, Faculty of P harmacy, Department of Pharmacentical Sciences
Abstract
Chinese remedies are prescribed after detailed examination of the patient's symptoms and diagnosis of the cause of the disease in accordance with the theory and principles of traditional Chinese medicine. Since the adoption of the 1982 China Constitution, the People's Republic of China has regulated traditional Chinese medicines and has made every effort to create an international market for its products. Documentary analysis has been used. The State Food and Drug Administration (SFDA) of China has the responsibility to formulate provisions on traditional Chinese medicines and to control their implementation, develop quality standards, and formulate good agricultural practices for the provision of raw materials used in the production. China also has a State Administration of Traditional Chinese Medicine (SATMC), whose only and main task is to regulate traditional Chinese medicines.Traditional Chinese medicines are subject to "strict pharmaceutical control," similar to that of medicines. China is trying to gain recognition in the international community so it can export its traditional Chinese medicines that have proven effective for centuries.
Key words: Legislation, Traditional Chinese medicines Introduction
In recent years, there has been an increasing interest in food products with health benefits, as the largest share in the supply and sales of foods with health claims have nutritional supplements. According to the International Alliance of Dietary Foods and Food Additives (IADSA), the global food supplement market exceeds $ 80 billion. A number of factors contribute to market growth:
there is a significant increase in consumers who want to improve their health and seek effective and affordable ways to achieve it; research results have accumulated in recent years proving the benefits of food supplements; the production and marketing of nutrients with positive health effects are increasing. During the last years consumers' access to food supplements has increased, grocery channels have grown - shops, pharmacies, direct sales, a range of specialized retail outlets, internet commerce, home delivery, or mail. Significant demand and use of food supplements, respectively, have a bearing on their production and supply, which has grown considerably in recent years. (Duleva V., 2015) A large part of the products on the market are combined products that require health claims. Numerous achievements and results from the development of science and biotechnology are increasingly the basis for developing new formulas, formulations, broadening the diversity of food supplements in the market for the effect of which scientific evidence exists. At the same time, for increasing the safety and free movement of goods, there is a higher demand for the regulation of food supplements as well both in Europe and globally. The specific characteristics of these products and their long history of use make it necessary to pay particular attention to food law. According to the World Health Organization, the Food Safety Authority and the European Food Safety Authority (EFSA), a significant number of dietary supplements, even those that have been known for a long time and produced by large companies ("recognized leaders") worldwide do not meet certain criteria of European legislation. (Duleva V., 2015)
The aim of our study is to evaluate the specificities of the food additive legislation in China. Methods
Documentary analysis has been used Results
Since thetransitionof the 1982 Chinese Constitution, the People'sRepublic of China (China) has regulated traditional Chinese medicines (TCMs) and is taking every effort to create an international market for its products. In the past, TCMs have not beenregulated by China, mostly because of their status as a culturalinstitution.Although TCMs have a history of long use by the Chinese, there is "little evidence of uniformity in the preparation, ingredients, and dosage of traditional Chinese medical treatments."(See LeCong) The State Food and Drug Administration (SFDA) of China has the responsibility to take charge of formulating regulations for TraditionalChinese Medicines (TCMs) and ethno-medicines, and further supervisetheir implementation, draw up quality standards ofTCMs and ethno-medicines, formulating Good AgriculturalPractices for Chinese crude drugs and Processing Standardsfor prepared slices of Chinese crude drugs and supervisingtheir implementation, and carry out protection systemfor certain TCMs. In addition to the SFDA, China also has the State Administrationof Traditional Chinese Medicine (SATMC) dedicated solely to regulatingTCMs. (GAO Report) National regulation of TCMs ramped up in 1992 with thetransition of the Regulations of Protection of Traditional Chinese Medicines,which seeks "to raise the quality of all varieties of traditionalChinese medicines, promote the development of TCM medicines,and perhaps most important - to protect the legal rights and interestsof enterprises engaged in the production of TCM." To receivea "Certificate of Variety of Traditional Chinese MedicineunderProtection," the TCMs must have clinical and scientific researchto support their efficacy and safety.(Schroeder T., 2002) Under the new regulationsystem, TCMs "are held to the same standards as otherChinese drug manufacturers. Under these new laws, all manufacturers,producers, and wholesalers must be licensed by local andnational agencies, all drug institutions are subject to investigation,and violation of the laws results in considerablefines and loss of license."TCMs are subjected to "rigorous pharmaceutical testing," similarto drugs. TCMs are generally categorized as a Category Ipharmaceutical, and they should meet special requirements, being TCMs. These requirements include providing informationregarding "sourcing, cultivation, ecological environment,collection,
handling, processing and preparation in the pretrialtesting phase. Only after final completion, reporting, and examinationmay the medicines be approved for production." (About SFDA,2010) China is now strongly interested in how TCMs are developedbecause China wants a piece ofthe dietary supplement pie. Sincethe 1960s, TCMs, especially acupuncture and herbalremedies,have developed an international following. The market for Chineseherbalmedicines doubled in ten years, with Europe and theUnited States being the major importers. China is responsiblefor 65% of raw exports to produceTCMs in other countries, but it isonly responsible for 2% of the finished TCM products internationally. (Qiu J.,2007) For finished TCM products, international consumers turn toneighboring countries, such as Japan or Korea, most likely becauseof the lack of standardization and quality control in China. China'snew regulations hope to globalize TCMs by 2020.Similar to the differences between the EU system of regulationand the U.S. system of regulation, China's regulations are muchmore strict than the regulations in the United States. "China's recentlyupdated pharmaceutical laws, which include regulation ofChinese herbal medicines, are better equipped than U.S. domesticlaws to ensure the quality of herbal remedies."163 China now requiresthat TCMs go through a premarket approval process thatthe DSHEA eliminated from the U.S. regulation system. Chinaenacted these regulations to be competitive in the internationaldietary supplement market by raising its standards for TCMs,which begs the question of why Americans are hesitant to purchaseChinese medicines, but hurry to the stores to buy Americandietary supplements, which are not regulated. (Schroeder,694)
Conclusion
China recognizes that a pre-market approval of Chinese dietary supplements is needed to assure them the recognition of being safe and effective. The pre-market approval will give the consumers proper information about the dietary supplements' ingredients and will guarantee that the supplements have the health benefits which they claim to, and that the government has the power to recall dangerous products from the market.
References
About SFDA: Main Responsibilities, STATE FOOD AND DRUG ADMINISTRATION, P.R.CHINA, http://eng.sfda.gov.cn/eng (last visited Aug. 29, 2010).
Duleva V., Aspects of food additives regulation in EU, 2015, National center for health assessment and analysis
GAO Report, supra note 3, at 6-7; Nowak, supra note 129, at 1068.
Jane Qiu, China Plans to Modernize Traditional Medicine, 446 NATURE 590, 590(2007).
SchroederT., Comment, Chinese Regulation of Traditional Chinese Medicinein the Modern
World: Can the Chinese Effectively Profit from One of Their Most ValuableCultural Resources?,
11 PAC. RIM. L.&POL'Y J. 687, 688 (2002).
Schroeder, supra note 148, at 697.
Schroeder, supra note 148, at 694.
See LeCong, supra note 90, at 108-09 (noting that manufacturers attempting toget substances added to the "positives list" face costly tests and a lengthy application process).
