Business News Agency July 12th The EU registration that deterred domestic Chinese medicine companies was gradually unveiled by Lanzhou Foci Pharmaceuticals' “crab”.

At the 2011 European Union Registered High Level Seminar held in Lanzhou, several experts explained the key points in the “EU Traditional Herbal Drugs Directive (2004/24/EC)” and gave the most practical implementation to the company. Suggest.

Procedures: Sweden and the Netherlands

According to the EU Directive for Traditional Herbal Medicines (2004/24/EC), all botanicals sold in the EU market must be registered in accordance with this new regulation and must be approved for marketing before they can continue to be sold. At the same time, the Directive stipulates that herbal products that have been sold as “non-pharmaceutical” in the EU market are allowed to be sold for another 7 years and sold until April 31, 2011, and allow the use of traditional herbal medicines to streamline applications for legal status. This requirement for a seven-year transitional period was once seriously misunderstood and was mistaken for a simple application by a Chinese medicine company after the transition period. This has also led to a doubling of pessimism on the export of Chinese medicine to the EU.

Ye Zuguang, the deputy director of the National Engineering Research Center for Traditional Chinese Medicine Compound Drug Development, which has just returned from a visit to the European Union for several days, corrects this view. “This is not to say that after the transition period, Chinese companies cannot apply for simple applications. The channel for simple application is always there. The transition period is only for products already sold in the EU."

According to reports, at present, there are three procedures when herbs are declared in Europe as drugs. One is a centralized examination and approval procedure, and the other is a non-centralized examination and approval procedure. This includes the examination and approval procedures of member states and the mutual recognition procedures among member states. Any traditional herbal medicine passes through this process. Three kinds of procedures are declared. Centralized examination and approval means that once a centralized examination and approval is passed, it will require that all EU member states accept the listing approval, and a total of 300 days of centralized review and review. "Concentrated approval is the most difficult one," said Zhuo Youzhen, executive director and general manager of Sweden Viccon Co., Ltd.

The so-called member states' approvals mean that EU member states carry out drug examinations and approvals. Mutual accreditation procedures mean that they are extended to other countries on the basis of member states. "For example, Foci applied for this time in Sweden. Then Sweden can be a reference country and can apply for Germany. France, this material can be transmitted from Sweden to other countries, and can be applied after listing. Both procedures can be carried out. If the reference country has already accepted the listing, other countries can not object without special reasons unless the herbal medicine is safe. Questions can be challenged, and another country can't say no approval. It must be decided by the superior," Ye Zuguang explained.

Due to the different strengths of EU countries in implementing the “EU Traditional Herbal Drugs Directive (2004/24/EC)”, comprehensively, it is relatively successful to apply from Sweden, the Netherlands and other member countries.

Variety: reduce compound products

According to reports, in accordance with the EU's Traditional Herbal Drugs Directive (2004/24/EC), the simplified registration procedure must meet five major conditions: traditional herbal products have clear functions and do not need to be used under the supervision of doctors; The number and cycle of use; Oral or external use, spray; There are sufficient scientific literature or experts to prove that the product has more than 30 years of use history, of which 15 years are used in EU countries; the product has sufficient data to prove and support the traditional use history, It does not cause harm to the human body. The effectiveness the product may have is based on long-term use and clinical experience.

In this regard, Zhuo Youzhen suggested: "At present, China's proprietary drugs have a very wide range of functions. Therefore, enterprises must make adjustments and applications should be made for major functions." Zhu Rongzu, general manager of Lanzhou Foci Pharmaceuticals, also stated that the concentrated application of Angelica Pills is Apply for blood enrichment to increase the likelihood of passing.

At the same time, Zhuo Youzhen said: “The most challenging issue in the application of the entire compound herbal medicine is that according to regulations, companies must label and quantify the active ingredients of each herb, intermediate and product contained in the product. Analysis and testing must be conducted in accordance with the “analytical methods” stipulated by the EU Pharmacopoeia.” Therefore, Ye Zuguang suggested that “the number of compounds should not be as large as possible because the compound products are treated completely as new drugs.” He disclosed that through the EU From the aspect of the communication, it was learned that the medicinal herbs contained below 5 flavours may be accepted, preferably below 3 flavours.

In addition, the evidence of “15-year history of EU use”, which is generally difficult for Chinese medicine companies, also shows more flexibility in actual operations. In addition to stipulating the accreditation of “customs import sales certificates or records; publicly published literature materials (most important); doctor's prescriptions; other; continuity and breadth of application”, Ye Zuguang also revealed several kinds of flexibility: First, the number of medicinal herbs or The same kind of herbal medicine with reduced dose and “simplification”; as long as medicines sold in the market can be calculated, it is not the time after approval for listing; even if there is no 15 years, it does not matter if scientific scientific data and literature data can be provided, It can be acceptable to prove that it is safe, but member states need to seek advice from the Herbal Council.

Regarding the expenses that the company was most concerned about before, Ye Zuguang probably calculated an account: "The registration fee is nearly 90,000 euros, the agency fee is 100,000 to 200,000 euros, and the European GMP expert on-site inspection fee is 100,000 to 200,000 euros. The review of sample quality standards for European-approved inspection units requires 100,000 to 150,000 euros for a single preparation, while compound preparations are expected to increase exponentially compared to that of a single party.” For Foushi Ci, it is estimated that the registration fee for concentrated Angelica Pills will be less than Previously reported by the media. (Author: Kangyi Yao)