In general EU legislation on pharmaceutical products for human use also applies to herbal medicines.In 2004 EU adopted a Directive to introduce a new pathway for marketing traditional herbal medicinal products,the "simplified registration" procedure.Subject to satisfying certain conditions,it allows the registration of traditional herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy,provided that there is sufficient evidence of a minimum 30 years medicinal use,including at least 15 years in the EU.Accordingly pharmaceutical companies should to be able in theory to save considerable expenditure of time,effort and money when applying for marketing authorization.But in practice the new pathway doesn't work out as smoothly as expected.This article analyze the various pieces of European legislation that affect the development of both modern and traditional herbal medicine,the continued growth of their demand,EU's response to the latest market trend,and how Chinese herbal medicine companies should grasp the opportunities to penetrate into the European market.It also stresses the fact that publication of Chinese medicine scientific research articles in international medical journals will be the key to the sector's future success.

Herbal products,either in the form of drugs,cosmetics or health food are increasingly popular in Europe.There are wide variations throughout Europe with regard to the quality and safety control of these products.In recent years EU begins to adopt a new wave of legislation aiming at harmonizing the law.While small and medium herbal companies may feel very difficult to tackle the legal restriction problems newly imposed upon them,some large pharmaceutical companies with adequate capital and technical know-how are showing keen interest in investing in herbal products for supply to the European market.Strategic alliance,merger and acquisitions,and industry restructuring activities will frequently take place in the foreseeable future.This article argues that although facing fierce market competition Chinese herbal companies are well positioned to expand their business in Europe.Besides it makes an in-depth analysis of a set of important rules and regulations concerning borderline products,labeling,packaging,health and nutrition claims;all of which are important legal issues deserving special attention of Chinese herbal companies.