China's proprietary Chinese medicine registration in the EU is expected to achieve zero breakthrough

Affected by Chinese traditional culture, China's exports of proprietary Chinese medicines are mainly concentrated in Asia, but the key to “going out” lies in the breakthrough of the European market.

Zui is near, the news that the Guangzhou Pharmaceutical Group's Qixing Pharmaceutical was awarded the “Simple Registration of Traditional Chinese Herbal Products and GMP Certification of the European Union (UK) Drugs” has been carried out in the industry, causing people to pay more attention to the Chinese medicine Westbound.

The reporter was informed that this is the first project in China to carry out the “EU Chinese Medicine Registration and GMP Certification”, and the United Kingdom is the country of certification and registration. Li Guangliang, chief executive of Qixing Pharmaceutical Co., Ltd. said in an interview that “the project has received great attention from the UK Medicines and Health Products Administration (MHRA), and China’s proprietary Chinese medicines are expected to achieve zero breakthroughs in the EU.”

In addition, in order to encourage Chinese medicine westward, the “Technical Guide for the Registration of Exported Drugs”, which is expected to be released recently, also emphasizes the importance of drug registration.

Just a matter of time

For a long time, the "identity" of Chinese medicine exports has been paralyzed, and the pace of "going out" of Chinese enterprises has been hampered. In March 2004, the European Union promulgated the "European Traditional Herbal Medicine Act", which stipulates that herbal products that enter the EU market before April 2004 can continue to be sold in the EU market, but must be registered before April 2011, otherwise Prohibited from sales.

"The seven-year deadline is approaching. China has not yet obtained the identity of a Chinese medicine company in the EU." Li Guangliang told reporters that this means that from April 2011, China's Chinese medicine will not be able to enter EU countries for sale.

By then, the EU will have a situation of "there is no Chinese medicine in Chinese medicine." Talking about this, Liu Zhongliang, the chairman of Zhejiang Weikang Pharmaceutical Co., Ltd., is also very worried. “The EU Directive requires that herbs be used for 30 years in safe use and have a 15-year history of use in the EU market to apply for a simple registration process.” Liu Zhongliang said that these harsh conditions have left many Chinese medicine companies far away.

In the interview, a number of Chinese patent medicine companies also revealed the same distress to reporters: “Without the drug status, the Chinese patent medicine market is shrinking, and registration is facing serious problems such as approval and clinical trials.”

In this regard, Professor Cai Yefeng of Guangdong Provincial Hospital of Traditional Chinese Medicine said that the difficulty in the export of Chinese proprietary medicines in China is that most countries have not yet accepted the Chinese medicine varieties under the guidance of Chinese medicine theory. Therefore, registration in the international mainstream market is currently the top issue.

Not long ago, the first batch of monographs published by the British Pharmacopoeia was intended to include 33 Chinese herbal medicines. Cai Yefeng was pleased to remind the company: “By entering the EU Pharmacopoeia to break through the 15 years of the history of the use of the EU market, the enterprise is worth a try. Of course, the identity of proprietary Chinese medicines has been restored by the government and it is believed to be 'recognition'. Just a matter of time."

Innovation is the key

In the first half of this year, the cumulative import and export volume of Chinese patent medicines reached US$152 million, down 5.79% year-on-year. The import and export volume of Chinese patent medicines accounted for 16.67% of the import and export volume of Chinese medicine products. Overall, the situation is not optimistic.

"This is a very obvious warning." Li Guangliang told reporters that in the future, exporting countries will become more and more standardized on the access standards and supervision of proprietary Chinese medicines. Some proprietary Chinese medicines that are not exported as non-pharmaceuticals will be restricted.

Of course, "not every export of proprietary Chinese medicines is declining. Products of well-known companies such as Guangzhou Pharmaceutical and Tongrentang have risen against the trend." Li Guangliang pointed out that one of the important reasons is that it targets different races and regions. These companies are constantly pursuing innovation in their products.
Liu Zhongliang is deeply impressed by this. "At present, domestic enterprises still don't know much about foreign markets, and they have no scientific experimental support and thus have long been outside the modern medical theory system." Liu Zhongliang said that the modernization of traditional Chinese medicine is a "squat" that Chinese medicine enterprises must take internationally.

Due to the influence of traditional Chinese culture, the export market of Chinese proprietary medicines is mainly concentrated in Asia, but the key to “going out” is in Europe. The European Union's herbal medicines are in full swing, and the Chinese Pharmacopoeia, which is particularly emphasized in the Chinese Pharmacopoeia, has been upgraded across the board, making Chinese patent medicines even more innovating.

"With people advocating natural remedies and increasing recognition of Chinese medicine culture, the overseas market of proprietary Chinese medicines continues to increase, but this is not a feast of equal opportunities. The technical barriers to the establishment of Chinese herbal medicines are increasing day by day, and it is necessary to break the development difficulties. Innovation is the only way to do it.” A person in charge of a Chinese medicine company told reporters that foreign herbal medicine manufacturers are also participating in competition.

Path choice

In addition to accelerating the pace of certification and adhering to technological innovation, path selection is also a hot topic for many companies. Some people think that they will get the US FDA certification as a drug, and then gradually strive to pass the mutual recognition of the EU, Japan and other countries. For example, Tasly's “Compound Danshen Dropping Pills”* has passed the US FDA's clinical drug application, which has won a considerable market. "The road to drug certification will be the 'golden key' to open the door to Europe and the United States."

However, drug certification often stops many companies because of the complexity and high cost of traditional Chinese medicine. In this regard, some people believe that through the breakthrough of sales terminals, the path of simultaneous development of Chinese medicine and traditional Chinese medicine is more likely to form a conceptual identity and win the market.

In addition, a person in charge of a Chinese medicine company in Guangdong told reporters that Chinese medicines cannot enter the EU market alone. They must break through "technical barriers" and carry out internal and external integration through cultural exchanges and foreign education. However, this is also a long-term, long-lasting process.

Talking about this, Liu Zhongliang feels the same. He did not hesitate to point out that there is no fixed path for Chinese medicine to go to sea, and it is mainly necessary to choose according to the actual situation of the enterprise and the product itself. For small and medium-sized enterprises, it is difficult to spread the traditional channels of overseas agents or pharmacies, and it is an expedient to take advantage of the terminal promotion.

"In addition, enterprises should be good at discovering the highlights of the state's supportive policies, taking the initiative to change their own and taking the characteristic route. At the same time, they should choose to register and certify the countries with high awareness of traditional medicines, especially Chinese medicines." Liu Zhongliang Say.

During the interview, the reporter found that “overseas registration + terminal promotion” has become the preferred path for many Chinese patent medicine companies. "This kind of combination boxing, from the perspective of economics, Zui is suitable for Chinese patent medicine enterprises with Chinese characteristics." Li Guangliang gave reporters an example. On October 12, several experts from Vietnam on "Stroke Clinical Academic and Huajing Reconstruction Pills" "Clinical application has carried out academic exchanges with researchers from Guangdong Provincial Hospital of Traditional Chinese Medicine and Qixing Pharmaceutical, and its terminal identification effect is obvious.

Li Guangliang further explained: "At the beginning of this year, the work registered in the EU has been launched, combined with academic promotion, which is why this year's Qixing Chinese patent medicine exports can maintain a trend of more than 20%."

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