What Are The Roadblocks For Traditional Chinese Medicine Export?
Nov 20, 2024
The development of traditional Chinese medicine in Europe has experienced several climaxes, the last of which was in the 1990s. In particular, the sales of Chinese herbal medicine slices increased several times in those 10 years. The author started his business in the import business of Chinese herbal medicine slices during that booming period. I remember that many old traditional German companies such as Martin Bauer, Klerk and Ce Luo were eager to enter the Chinese herbal medicine slice market. Twenty or thirty years have passed, and the German Chinese medicine market is currently in a stable development stage.
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According to the information I have, the current German Chinese medicine market is divided into half by slices and single-ingredient formula granules, each with a market size of about 25 million euros. Chinese patent medicines that enter the market as drugs can be ignored, and more of them take the edge ball approach and enter the market in the name of functional and health food. So far, only 7 Chinese patent medicines have been successfully registered in accordance with Directive 2004/24/EC (European Commission): Dior Xinxuekang Capsules, Danshen Capsules, Isatis Root Granules, Yufeng Ningxin Tablets, Liujunzi Decoction, and Xiaoyao Tablets. In 2023, Yamato Gast (Heweikang), a Chinese medicine produced in Japan, was successfully registered in Germany.
As an industry insider who has been working in the German TCM industry for nearly 30 years, the question most often asked by domestic peers is: what is the status of TCM in Germany? Therefore, I feel it is necessary to share what I have seen and heard.
Which TCM can enter Germany?
Some people are very concerned about the pesticide residues, heavy metals and microbial indicators of TCM, and ask whether the customs will release TCM with excessive harmful pollutants. In fact, the quality of TCM is not within the scope of customs supervision responsibility. Unless there is a special administrative order, the customs generally does not judge whether it is on the negative list based on the category attributes rather than the quality of the TCM, and then decide whether to release it. The pharmaceutical and food regulatory authorities can temporarily include a certain product in the negative list, such as the EU once included wolfberry in the negative list. Because wolfberry suddenly became a popular magical functional food in Europe at that time, hundreds of growers in core production areas such as Gansu and Ningxia obtained EU organic certification overnight.Later, a sampling inspection found that many "organic" wolfberries from China
As an industry insider who has been working in the German TCM industry for nearly 30 years, the question most often asked by domestic peers is: what is the status of TCM in Germany? Therefore, I feel it is necessary to share what I have seen and heard.
Traditional Chinese Herb Cistanche For Overall Health
Which TCM can enter Germany?
Some people are very concerned about the pesticide residues, heavy metals and microbial indicators of TCM, and ask whether the customs will release TCM with excessive harmful pollutants. In fact, the quality of TCM is not within the scope of customs supervision responsibility. Unless there is a special administrative order, the customs generally does not judge whether it is on the negative list based on the category attributes rather than the quality of the TCM, and then decide whether to release it. The pharmaceutical and food regulatory authorities can temporarily include a certain product in the negative list, such as the EU once included wolfberry in the negative list. Because wolfberry suddenly became a popular magical functional food in Europe at that time, hundreds of growers in core production areas such as Gansu and Ningxia obtained EU organic certification overnight.
Later, a sampling inspection found that many "organic" wolfberries from China
The author explains the basic knowledge of Chinese medicine to German TCM enthusiasts at the Confucius Institute in Munich
The pesticide residues are excessive and do not meet the EU organic standards. At present, although the EU has long lifted the import ban on organic wolfberries, many additional harsh conditions have been added to the certification of organic wolfberries in China. From the source of production to every transaction link, strict real-time tracking and supervision of each batch has led to a sharp increase in the cost of organic certification. Product prices have also soared, and the market has basically been lost in the EU.
Among the more than 300 commonly used Chinese herbal medicines, except for a few that are subject to regulatory restrictions under the Convention on the Protection of Endangered Species of Wild Fauna and Flora (such as tiger bones, rhinoceros horns, costusroot, dendrobium, gastrodia, American ginseng, dog spine, white hyacinth, etc.) or poisonous hemp varieties (such as ephedra) during import and export trade, the others are not included in the German customs negative list. Since the COVID-19 pandemic, the EU has significantly stepped up entry quarantine and prevention and control measures for biological products and animal-by-products. Many important Chinese herbal medicines such as cicada molts, chicken gizzard lining, white silkworm, and even oysters, semen cassiae, mother-of-pearl and other shellfish belong to this category. In fact, they are gradually fading out of the EU market, which is undoubtedly adding insult to injury for traditional Chinese medicine, which is already struggling in Europe.
In 2009, Bavaria was the last state to abolish drug regulation of single-ingredient Chinese herbal medicine slices through an administrative order, ending the situation in which the legal status of Chinese herbal medicine slices was not uniformly defined in various German states. Prior to this, importers of herbal medicine slices had to apply for import licenses in accordance with Article 72a of the German Drug Law, provided that the importer was actually regarded as a drug manufacturer and assumed all responsibilities for the products it imported. Chinese herbal medicine slice manufacturers must accept the GMP (Good Manufacturing Practice) acceptance of the German drug regulatory authorities. Only after passing the acceptance can the Chinese herbal medicine slices they produce be allowed to enter Germany. Animal-based Chinese herbal medicine slices are still managed in accordance with "active pharmaceutical substances" (API). Chinese manufacturers and exporters and German importers must register and apply to enter the EU TRACES (EU Trade Monitoring Database for Animals and Animal Products) system. None of the Chinese Chinese herbal medicine manufacturers and exporters knew about this problem, let alone consult the relevant competent authorities to solve this problem, understand the relevant international trade treaties, register in accordance with regulations, enter the TRACES system, handle the relevant quality qualifications and quarantine procedures for the products, and open up channels for the legal export of animal-based Chinese medicine. Following the author's suggestion, Anhui Jiren Pharmaceutical Group actively cooperated and became the first Chinese herbal medicine manufacturer to register with the customs and enter the EU TRACES system.
The Pharmacognosy Committee of the German Pharmacopoeia Commission of the German Medical Products Administration holds expert meetings twice a year to discuss the drafting of the Chinese medicine monograph for the European Pharmacopoeia.
Chinese herbal formula granules have always been managed as medicines in Germany.
Although other EU countries do not consider formula granules to be medicines. However, the German Federal Administrative Court made a final ruling on the legal status of Chinese herbal formula granules on March 3, 2011: single-ingredient formula granules can be considered a "promoted medicine", which means that they can be used without further substantial processing. Ordinary consumers intuitively identify the packaging as a product for treating diseases. From this point on, the formula granules on the German market are not directly imported, but are imported from third countries in the EU.
As for Chinese patent medicines, it is even more difficult to enter the EU. Except for a few Chinese patent medicines that have been successfully registered in the EU, all Chinese patent medicines cannot enter the European market as medicines. The Chinese patent medicines seen now are actually smuggled goods or imported in a veiled manner under the name of health tea, health products or functional foods. According to Article 73, paragraph 3 of the German Drug Law, Chinese patent medicines can also enter Germany as medicines, provided that they are imported in small quantities for individual patients by legal German pharmacies based on doctors' prescriptions. This does not make any sense in terms of commercial operations, but it opens a humanitarian loophole for special emergency patients.
Chinese medicine pieces warehouse of Dezhongtang Company in Germany
Western Chinese medicine practitioners show the pulse of traditional Chinese medicine
