The Analysis Of The Barriers On Proprietary Chinese Medicines' Registration In EU And Its Solutions Based On The Whole Registration Process

TCM of China has long been exported to EU as non-medical product like food or food supplement.Directive 2004/24/EC is published in 2004 and it sets simplified registration procedure for those traditional herbal medicinal products which have long been used with certain safety,and it provides proprietary Chinese medicines with opportunities to enter into EU market as drug.However,only two proprietary Chinese medicines got permission from Netherlands till now.This paper firstly analyzes the current status on proprietary Chinese medicines' export to EU and then introduces the medical administration system of EU nowadays.All possible registration types and corresponding approval routes are then listed to be analyzed,and THMP registration with TUR is then considered the most reasonable registration route.The difficulties in the registration are then determined by analyzing the application dossier and quality requirement under Directive 2004/24/EC.After analyzing all the difficulties,the main difficulty is determined as "lack of medicinal use of 15 years at least",and the related EU monograph is determined as breakthrough point.The EU monograph is then introduced and analyzed on how to be included in it.The statistical analysis on the evaluation and approval of EU member states of THMP/HMP is carried out to determine the key issues in application and approval.In the end,suggestions are made on promoting the entry of proprietary Chinese medicines to EU as drugs to the government and companies.