Chinese herbal medicinal products in Europe:sales prospect and legal issues / 中华中医药杂志

ABSTRACT

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.