[Difficulties in registration for export of traditional Chinese medicines to EU under directive 2004/24/EC and countermeasures]

Abstract

During the seven-year transitional period of European Union Directive 2004/24/EC, only a few of traditional Chinese medicines had been approved for registration. In other words, the EU directive has become an unavoidable registration barrier to hinder Chinese enterprises from entering EU market. By analyzing difficulties of enterprises in registration in EU and studying the only successful case in China--Di Ao Group, this article proposes countermeasures in the hope of providing effective reference for Chinese enterprises in expanding EU market, and promoting the internationalization progress of traditional Chinese medicine.