Ask the European Union enterprise

scruples and traditional Chinese medicine

Healthday reporter xue original

So far this year April 30 still not a traditional Chinese medicine enterprise through the eu's simplified application process, Chinese traditional medicine will exit the eu market news that a lot of people to accept. Lanzhou Buddha has kindness pharmaceutical Co., LTD to Sweden drug agency submitted the first application for the registration of proprietary Chinese medicine, Chinese traditional medicine the eu registered dawn again.

According to information, the Swedish national drug administration already in June 17 started the audit procedures, to Buddha kindness to return the concentrated pharmaceutical pills registered for formal approval, and the final results will be on the review within 220 days of forthcoming.

"Before the request to domestic to have many questions and guess. Enterprise only practical operation, can truly understand the instructions on executive power and European countries for examination and approval of the way." One industry experts convened by 2011 in the Chinese traditional medicine the eu registered symposium on top of the enterprise, said before the traditional herbal medicinal drug instructions "the understanding of error, registered and have no imagination of so difficult, not like the media reported that bad.

Read the eu instructions media

Buddha kindness to become the first application for pharmaceutical eu natural drugs registered enterprise no accident. It is the first time China's traditional Chinese medicine export, the most varieties of export enterprise, the product coverage of the United States, Canada, Japan, Australia and other 27 countries and regions.

According to the Buddha Keats introduces, they ZhuRongZu pharmaceutical general manager from five years ago and has started for registered and effort. Choose the Great Britain as the first applied country, but because the British laws and regulations and other European Union countries, apply for the difference in the high cost and give up. Two years ago kindness to become Buddha for Sweden. The reason is here to traditional Chinese medicine awareness and acceptance is very high.

The eu's instructions, "are fully put forward the scientific literature or experts proof products in the European Union have 15 years of use history." Had been approved is enterprise that the main obstacle, but in fact the European Union and no way to change completely. ZhuRongZu said, the proof of the earliest kindness pharmaceutical found in 1896, a German pharmaceutical factory in Sweden's application of proof, the prescription and advertising ZhangTieHua as to disclose the information.

Instructions for production conditions in also have request, but still may bypass the high standards of the state. According to introducing, many Chinese traditional Chinese medicine production enterprise passed the Australian TGA (equivalent to our GMP authentication authentication), and Australia is PIC (drug inspection agreement), its members and members of Britain, France, Germany, Canada, etc, the member of the cGMP is mutual recognition between. There is the shortcut, the enterprise is directly to the European multinational cGMP certificate.

According to some media coverage of the "Chinese medicine lose with the drug identity access to the eu last chance", experts also explains: traditional Chinese medicine can still summary in the future, not like some registered media can only go register normally channel, just that this year, according to the instructions on April 30,, the Chinese medicine after without registration will be from the eu market exit. But according to information, a lot of countries of the European Union and no instructions to the European Union, management, the most strict Britain also just don't allow to import, have entered the UK still can continue to sell.

Go to the European Union to sell medicine is a "make call the"

Before this, Chinese traditional medicine in the European Union in the form of health food sales, and food labels and manual management is very strict, can't write any indication. So the sales process also can only rely on the doctor recommended, the effect of one-on-one promotion was not good. If the registration successful, Chinese traditional medicine in the eu market, can not only marked indication, can also enter pharmacy, hospitals and other main channel.

So it seems, registered in a certain extent, to promote the sales of drugs, but in the short term it difficult to recover the cost of registration. The current enrichment angelica shot in the European sales of less than $500000, and of which the application for registration fees have reached 1.5 million yuan. "Was the choice of enrichment angelica pill, because the cost of the medicine prescribed study is quite low. If the light is JingJiZhang, affirmation is not cost-effective. Sales to only $500000 net profit, can have? How many years to back to this?" ZhuRongZu think, their more attention is paid to the authentication of the influence of the traditional Chinese medicine internationalization. Some think, Buddha registered the effect of advertisement kindness is more apparent.

Not only is a gentleness, many domestic Chinese medicine production enterprise are on the move. According to information, some of the medicine 2011 tongren temple will reach "in the European Union use 15 years," the conditions, the registered is ongoing. In addition, the singular star pharmaceutical, Yangtze river pharmaceutical etc also in related work.

Traditional Chinese medicine (TCM) and development of new national engineering research center, executive deputy director YeZuGuang not long ago from Europe return. Investigation He help enterprise calculate a bill: registration fee, nearly 90000 euros 100000 to 200000 euros, Europe GMP experts on the inspection fee 100000 ~ 200000 euros, in addition, about Europe recognized surveyors sample quality standard review unit, prescribed preparations need 100000 ~ 150000 euros ($), compound preparations was unilaterally to increase exponentially. But for the product, many enterprises have to challenge the limit of difficult compound preparations.

Qixing pharmaceutical is doing is going to put 11 taste of medicine of rhinitis submitted to UK registered. Marketing center director YuanKeLun introduces, although Chinese medicine from a relatively easy to the breach of the European Union, but can enter from one country to another country or need to evaluate, only relative to simplify the application procedure. From the UK into the European Union really difficult, but the main market of rhinitis in Britain.

Chemical medicine overseas crowd out Chinese traditional medicine

The seminar held in lanzhou attracts many enterprise, but the enterprise of the reaction is not optimistic, mostly in the "serious concern" watching the state. On one hand, application for traditional Chinese medicine "becomes" is a chance, but on the other hand, a large application fee and faces an uncertain future European market so they flinch.

"Enterprise get written instructions to a subordinate is one thing, increasing sales volume is another matter, European local enterprises will crowd out traditional Chinese medicine." YuanKeLun the development of the traditional Chinese medicine in Europe is not optimistic.

A Chinese traditional medicine enterprise of Europe manager told reporters, the registration is only the first step, now do not look good in the traditional Chinese medicine enterprise, even if the prospect of traditional Chinese medicine really fulfill a wish to enter the hospital and medical insurance, also can't avoid chemical medicine of traditional Chinese medicine to question and rejection. The enterprise of a product ever enter the eastern Europe market, but many chemical pharmaceutical factory house and then blame the quality standards of Chinese traditional medicine and safety issues, also to please the media experts questioned the traditional Chinese medicine, and send such words will obviously be influence the judgment of the patients, so their products in local sales is not good. "Foreign various speech to domestic, or even affect the main market of traditional Chinese medicine. If that's the case, the loss outweights the gain......."

In the interview, enterprise puts forward the government can in Chinese medicine in the process of international play a larger role. They think, China and the European Union in Chinese medicine on the question of registered lack systematic docking, the government did not know the eu regulations, but need to scout in enterprise. Our country can draw lessons from the south Korean government promotion HanFang medicine and Korea meal from doing the government from the point of view of the traditional Chinese medicine to further promote the.

Obviously, the government has realized the importance of internationalization of Chinese medicine, deputy minister of health, the state administration of traditional Chinese medicine director WangGuoJiang in seminar that for the next 10 years is to realize comprehensive trend of Chinese medicine international, in the world, a richer and critical period of development, we must put the development of Chinese medicine into national development strategic framework, give full play to the foreign exchange and cooperation of Chinese medicine advantage and function, and grasp the correct development direction.