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| Chinese and western medicine entered Europe and the United States: international review of the thought analysis and the approval of the variety of experience |
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| Author：中國銘鉉 企劃部 Release Time：2017-8-30 10:28:44 Number Browse：709 |
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On August 30th, the website of the bulletin board of the medical network, the blue root granule finally got the "ticket" of the British market. Recently, a wholly owned subsidiary xiangxue pharmacy xiangxue Cambridge international Chinese medicine research center (hereinafter referred to as the "Cambridge, fragrant snow") received the British drug and health product administration (hereinafter referred to as "the MHRA") of the notice.
It has always been the focus of domestic drug companies to get access to mainstream medical market in Europe and America. Submitted to the MHRA xiangxue Cambridge, radix isatidis products used to treat cold and flu registration approved by the review, became the first declaration of traditional Chinese medicine according to requirements of the eu directive, which is China's traditional Chinese medicine internationalization development milestone.
It is widely believed in the industry that if the us and Europe register successfully, it will open the door for Chinese medicine to enter the international market and have a positive and far-reaching impact on the future sales in the us and Europe.
There are many levels of internationalization
But registration is not easy. The European Union in 2004 issued the traditional plant medicine registration program instructions for traditional Chinese medicine as a treatment drug into the eu drug market has provided a legal basis, also for traditional Chinese medicine into the mainstream European plant medicine market and European drug distribution channels.
The instructions for use was the eu herbal medicine, set sales transition rules all the eu market sales of proprietary Chinese medicine must complete registration during this period, in accordance with the new rules, and get the authorisation, otherwise will not be allowed to sell. Before the directive came into force, most of the eu-market drugs were circulated in the form of food, health products or plant medicine ingredients. Over the next few years, the number of botanicals registered in the European Union increased year by year. But because the registration difficulty is higher, the cycle is longer and the registration fee is expensive, the variety of Chinese drug companies to register the approval document is very few.
In medicine economic newspaper reporter interview, said xiangxue pharmacy, Britain from eu rules came into force in 2011, proprietary Chinese medicine products must get registration license, no registration license of proprietary Chinese medicine inventory pin out, after the shelf life can't be restocked. In 2013, the UK's medicines and health products administration announced a full ban on unregistered herbal products from April 30, 2014, in order to further help people buy and use safe herbal products.
In the view of the enterprise, the difficulty of the eu declaration is "insufficient time limit evidence". Tasly international marketing Dai Biao holdings co., LTD. General manager after the medicine economic newspaper reporter is introduced, the eu directive rules, apply for simplified plant drug products must be registered "with 30 years of using history, including use in the eu has 15 years of history", the use of the most traditional Chinese medicine products in Europe is difficult to meet the requirements.
The simple registration of "traditional herbal products" is exempted from the test requirements for effectiveness and safety, and the emphasis is naturally placed on the quality standards. In the interview, kang zhiying, director of technical support of xiangxue pharmaceutical company, told the medical economics newspaper that the application for registration should meet the standard of European production quality management (eu GMP). "And the requirements of the European Union is the world's most tightly, almost enterprise production workshop, equipment and so on need to be modified, even the hardware equipment has a good enterprise, due to the less attention, software and other management level is only to modify the original management system cost a lot."
In contrast to eu registration, the FDA's application for a Chinese medicine listing license is similarly stringent. "Go through pre-clinical, stage Ⅰ, Ⅱ period, Ⅲ after clinical, to gain recognition." In an interview with the media, an expert from the China association for the advancement of traditional Chinese medicine said it would not be suitable for traditional Chinese medicine if it were solely from the FDA's review system. For example, the FDA review requires that the chemical components of the drug be clear, and the relationship between ingredients, dosage and efficacy is clear, but the ingredients in traditional Chinese medicine are many and complex, and it is difficult to be clear.
Due to the relatively high cost of registration in Europe and the United States, in the case of uncertain returns, a lot of enterprises are seen to be more and more on the sidelines. According to the headquarters in Britain's natural health alliance estimates that even the eu pharmaceutical enterprise, registered the cost of a plant medicine also needs 80000-120000 pounds, or about 860000 ~ 860000 yuan, the larger plant medicine products on sales is okay, but some small businesses will be shut out.
Although the international road is long and difficult, there are already some pioneer varieties to enter the international market. For example, the underground of the diao group is approved by the Netherlands to obtain the listing license. Tianshili modern Chinese medicine danshen capsule obtained the European Union plant medicine registration approval, successfully entered the European market as a drug. In addition, Shanghai and huang pharmaceutical production of chin-chinning tablets obtained the Canadian listing license; Centralizer blood piece in modern Chinese medicine co., LTD. Of Shanghai, tasly pharmaceutical compound danshen dropping pill, green leaves has applied for registration in the United States FDA certification, such as: China now has four kinds of traditional Chinese medicine get approved by FDA Ⅲ period clinical study.
The review attaches importance to safety and efficacy
"The core issue of TCM registration is safety, efficiency and quality control, especially the evidence of effectiveness. Enterprises should start with single or small compound. In addition, familiarity with regulations, close communication, and periodic summaries are essential links. A leading expert in the Shanghai institute of medicine, the Chinese academy of sciences, advises.
In an interview with the medical economic news, kang also Shared some of the details of the registration and highlighted how to pass the "checkpoint".
In accordance with the requirements, the traditional Chinese medicine (TCM) registered need to submit the product feature profile, pharmaceutical experiment study and quality study, 15 years in the European Union to use evidence, doctors application declaration certificate, certificate of product safety related information. The source and quality control of raw materials and other raw materials and the quality control of intermediate products to finished products are of particular concern. Europe has strict requirements on the planting environment and extraction process of traditional Chinese medicine plants, and has a very meticulous management regulations. However, some test methods and data of traditional Chinese medicine are not recognized by each other.
In particular, in the application of medicinal materials, it is better to be the herb of GAP base, and to provide such reports as heavy metal testing, agricultural residue test, marker or active component content. Review of experts in a massive search when they review reports of the medicinal material world literature, if you have any similar toxicology or could potentially toxic sensitization composition, will ask, should be added ShenBaoFang research data to prove the safety of the product. According to kang zhiying, in this link, xiangxue has repeatedly supplemented research materials including the control of the thyroid gland, the control of salicylic acid and the safety evaluation. At the same time, the control of weed components in the process of medicinal plants was controlled, and 29 weeds were set in the standard of the blue root products to control the content of the content of the PA term, to control the safety of the final product.
In the control of intermediate products, it also focuses on the safety index, and sets up more than 100 test indexes including solvent residue and heavy metal control, agricultural residue control and microbiological control. And all tests need to be done in an accredited institution, and even the European pharmacopoeia requires methodological verification, such as disability.
In the quality control of finished products, the control indexes of active ingredients are added and the safety indicators are added.
In addition, the expert is very concerned about the content of toxicology and clinical application evidence, especially the genetic toxicity, which is required to carry out the micronuclear test in vivo. In addition, reproductive toxicity and genetic toxicity are required to provide experimental data, and the experiment needs to be carried out by MHRA accredited institutions in the UK. The data of GLP laboratories in China can only be used for reference.
"The UK is registered from the material declaration, to review the review, supplementary information will be defended, the process is very rigorous." Kang Zhiying also said, however, "the MHRA has good communication mechanism in the review process, put forward the question will be send to ShenBaoFang filed, and set a time and opportunity to answer on the spot, some problems can ShenBaoFang complaint reply on the spot, don't need to add the data after approved."
The performance of the market can still be a trap
For the long time, the export volume and export volume of Chinese medicine products are the largest and the proportion of Chinese medicine is not high. The reporter understands from Chinese medicine and health products import and export chamber of commerce, 2016 year products including traditional Chinese medicine and Chinese traditional medicine yinpian, proprietary Chinese medicine, extract and health care products exports are in negative growth, "double down", the total volume of proprietary Chinese medicine exports of $225 million, down 13.94% year-on-year. "It is expected to reach $250 million this year." Yu zhibin, director of the Chinese medicine department of the Chinese medical insurance association, told the medical economic daily.
In the eyes of industry insiders, international markets, especially the European plant medicine market, are large in size, and the registration surface of the European Union is recognized as a drug identity, and behind it is a potentially huge market. In fact, compared with the popular and well-received Chinese medicine, the performance of Chinese medicine in the international market still can be seen.
Yu zhibin told reporters that the target market for Chinese medicine is mainly in Japan, which is rarely exported and has a low share of international market. In recent years, the export value of Japanese herbal medicine has averaged about $30 million, and China has exported $250 million worth of Chinese medicine. Japan's domestic market share is about 7 billion yuan, and Chinese traditional Chinese medicine is worth about 700 billion yuan. From the existing data, whether domestic sales or exports, Chinese medicine and traditional Chinese medicine are not equal.
For the domestic market, the international certification of pharmaceutical products has always been a grouped index and bonus points, and the score points are higher, and the advantages of such drugs will become more and more obvious in the future. There is a market, he says, is "domestic drug product if certified by European and American developed countries, may in the tender when access to higher quality level or separate product quality level, will significantly benefit."
Other industry sources pointed out that the drug certification in Europe and America is recognized by many countries and regions around the world. If you have obtained the certification of European and American countries, you may have great help in simplifying procedures and accelerating progress in the application of drug testing and certification in other countries.
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