Study On The Evaluation System Of EU Simplified Registration Of Compound Chinese Patent Medicine

Objective: Compound Chinese patent medicine is the main form for treating diseases in traditional Chinese medicine.The European Union simplified registration of traditional herbal medicines directive(2004/24/EC)provided a simple way for Chinese patent medicines to enter the EU market as medicines.Until now,there are only three single Chinese patent medicines registered in the EU,but no compounds.This paper took traditional Chinese medicine enterprises as the research object.By studying the EU drug registration regulations and standards,this paper discussed the factors affecting of the EU simplified registration on compound Chinese patent medicines,and established the evaluation system and the fuzzy comprehensive evaluation model.Z enterprise was taken as an example to study the actual progress of the EU registration project.Solutions and suggestions were proposed for the difficulties,in order to provide reference for the simplified EU registration of compound Chinese patent medicines of traditional Chinese medicine enterprises.Methods: The methods of literature research,Delphi expert consultation,fuzzy comprehensive evaluation and statistical analysis are used in this study.On the basis of literature research,the expert consultation questionnaire was formed;then two rounds of questionnaire surveys were launched to establish the evaluation system.Finally,the fuzzy comprehensive evaluation model was used to evaluate the three compound Chinese patent medicines of Z enterprise that have been listed in China.Results:(1)Through Delphi expert consultation method,2 first-level indicators,3second-level indicators,18 third-level indicators and the weights of each indicator were obtained.The first-level indicators are drug quality(50.03%),drug safety and efficacy(49.97%).The second-level indicators are quality of raw materials(33.57%),quality of final products(33.60%),and suitability of the registered species and directive requirements(32.83%).The third-level indicators are planting base selection of herb(5.34%),cultivation of herb(5.26%),collection of herb(5.70%),storage and transportation of herb(5.48%),quality control of herb(5.93%),quality control of excipients and packing materials(5.86%),production quality management(5.78%),production staffing(5.30%),productionplant and equipment(5.05%),production documents(5.78%),production process(5.76%),production quality control(5.93%),without mineral and animal substance(5.31%),special indications and no need to be used under the guidance of doctors(5.38%),oral,topical and/or inhalation preparation(5.48%),specific administration of medicine consistent with certain specifications and dosage(5.07%),clinical use with more than 30 years and EU use history with more than 15 years(5.82%),and sufficient data of effecacy and safety in long-term clinical use(5.77%).(2)Fuzzy comprehensive evaluation method was used to build the model,and evaluate the three compounds A,B and C of Z enterprise;the results were A 0.2641 > B 0.2559 > C 0.2515,which displayed that compound A is the most suitable for the EU simplified registration.Conclusion: The evaluation system and evaluation model of compound Chinese patent medicines of EU simplified registration by Delphi expert consultation and fuzzy comprehensive evaluation have high authority,strong scientific rationality and high accuracy,which can provide reference for EU simplified registration of compound Chinese patent medicines.Through the study on the EU registration project of drug A in enterprise Z,the difficulties in the process are as follows: First,the work of pharmaceutical research is heavy and staff are in short supply;Second,some Chinese medicinal substances contained in drug A have no EU quality standards.The solutions are: First,set up a scientific and reasonable professional team with excellent technology;Second,further study EU regulations and standards and establish quality standards for Chinese medicinal materials that meet EU standards with the characteristics of traditional Chinese medicine.For the EU simplified registration of compound Chinese patent medicines in TCM enterprises,we proposed the following proposals: First,combined with China's drug standards and ICH standards,research on EU standards for Chinese medicine;Second,strengthen the quality control of drugs;Third,pay close attention to the data collection of adverse reactions after drug listing;Forth,select reasonable compounds for EU simplified registration.