Whether Traditional Chinese Medicine Registration in EU Traditional Herbal Medicines Can Achieve Zero Breakthrough

On June 1, 2011, Lanzhou Foci officially filed a registration for Chinese medicine products with the Swedish National Drug Administration. According to the EU's traditional herbal medicine registration work schedule, 210 days were the approval time and 90 days were the resolution. In other words, by April of next year, whether the registration of traditional Chinese medicines in the EU's traditional herbal medicines can achieve a “zero” breakthrough will be clear.

As the European Union raises the threshold for the registration of traditional plant medicines, only Chinese herbal extracts can still be sold in the form of food or food supplements. In this context, the European market seems to have shut Chinese patent medicines out. The high registration fees and high thresholds have deterred many Chinese medicine companies. Since none of the Chinese proprietary Chinese medicines were successfully registered in the European Union during the 7-year transitional period, the pessimistic argument that traditional Chinese medicines could not adapt to Western standards and the internationalization of Chinese medicines went into a "dead end" was also stunned.

Yang Yuhua, director of the Center for New Product Research and Development of Lanzhou Foci Pharmaceuticals Co., Ltd. believes that the “simple registration” procedure stipulated in the new directive greatly improves the registration of Chinese patent medicines in the form of pharmaceuticals compared with the requirements of the “European Community Drug Use Registration Directive”. The possibility of sales objectively provides an opportunity for Chinese medicine products to enter the EU market in the form of drugs.

On June 1, 2011, Lanzhou Foci officially filed a registration for Chinese medicine products with the Swedish National Drug Administration. According to the EU's traditional herbal medicine registration work schedule, 210 days were the approval time and 90 days were the resolution. In other words, if the registration is successful as of April next year, Foci will be the first Chinese company to successfully register traditional herbal medicines in the European Union.

In fact, as early as 2006, Lanzhou Foci had submitted an application, but due to improper product selection, it was not successful. Two years ago, Foci Ci re-screened varieties and prepared data, determined that Angelica Pill, an Angelica monosodium glutamate product, was used as a registered species, used Sweden as the first country to apply for registration, and chose to assist the old Chinese brand “Huaqi” acupuncture needles. Sweden Wellcome, which successfully registered products in Sweden and EU countries, is a registered agent and cooperates.

This time, in the materials submitted to the Swedish National Drug Administration, Lanzhou Foci refers to the relevant technical indicators detection methods of the European Pharmacopoeia, the WHO Pharmacopoeia and the British Pharmacopoeia, and establishes medicinal materials, semi-finished products and preparations from Chinese angelica. Pills) A comprehensive system of quality control standards. Especially for Chinese angelica medicinal herbs and finished products in the “Chinese Pharmacopoeia” and the Ministry of Medicine for the Chinese medicines standard test items, 18 pesticide residue and heavy metal tests were added, and the range of upper and lower limit of ferulic acid content control and microbial detection (medicinal materials) were established. , organic solvent ethanol residue detection (finished product) and other standards.

As a result of these efforts, the Chinese angelica medicinal materials standard contained in the “Chinese Pharmacopoeia” (2005 edition) and the “Standard for Concentrated Angelica Pills” drafted by Foci have become the National Drug Agency of Sweden. One of the three approvals of the pill pre-assessment material.

Despite the encouraging progress made by Lanzhou Foci, the lack of protection of intellectual property rights in traditional Chinese medicine, the lack of international standards, the weakness of personnel training, and the rise in raw material prices have greatly constrained the internationalization of traditional Chinese medicine. Due to the long-term lack of awareness of intellectual property protection, Chinese proprietary Chinese medicine prescriptions are basically open. The state secret formula is only Yunnan Baiyao and Pien Tze Huang.

The lack of international standards is also a major obstacle to Chinese medicine going to the international market. At present, there are no internationally accepted standards for Chinese medicines. This has led many pharmaceutical companies to fail in the face of the international market and is always in a passive position in international competition. In this regard, Yang Yuhua believes that in order to solve this problem, it is necessary to further refine the standards for heavy metal and pesticide residues on the basis of respecting domestic Chinese medicine standards, and formulate internationally accepted Chinese medicine standards from the national perspective.

The development of traditional Chinese medicine is inseparable from the clinical work of traditional Chinese medicine. However, due to the long time and complex process of personnel training, and the excessive abstraction of medical science, training of Chinese medicine personnel in China is increasingly weak. Due to the limited profitability of traditional Chinese medicine and other factors, traditional Chinese medicine is often the “disadvantaged section” in major hospitals, which further exacerbates the loss of TCM talents, resulting in weak clinical development of TCM.