From October 10th to 12th, the seminar on EU THMP Registration was successfully held in Beijing. Sponsored by MOC of PRC and Directorate-General for Health and Consumers of the European Commission, supported by CCCMHPIE and EU-China Trade Project (Ⅱ), the seminar was presented by a total of over 160 representatives from 75 enterprises, as well as Chairman Werner Knöss, Vice Chairman Ioanna Chinou and committee member Per Claeson of European Medicines Agency (EMA) Herbal Committee, Yin Weijing and Li Biqing, Director of WTO Affairs of MOC, He Li, Director of International Cooperation and Chen Yixin, Director of Drug Registration of SFDA, Wu Zhendou, director of SATCM International Cooperation, and Vice Chairman Liu Zhanglin of CCCMHPIE. Baoling, Deputy Director of Foreign Trade at China's Ministry of Commerce and Mrs Benassi, first conselor of EU mission in China addressed the seminar. The seminar was cohosted by He Chunhong, deputy director of Technical Service Center of CCCMHPIE, and Mr. Barker, Chief expert of EU-China Trade Project.
At the seminar, EU experts introduced the relationships among EMA, Herbal Committee and responsible organs of EU members, elaborated on the EU THM law 2001/83 and 2004/24, explained EU’s requirements on the quality, effectiveness and safety of THM, EU Pharmacopoeia and contents of the Direction, and also put forward 7 questions associated with relative legal and regulatory frameworks of the EU. Lanzhou Foci Pharmaceutical Co., LTD shared their experience of registering angelica pill in Sweden. During the seminar, plenty of time were given to the EU experts and enterprises representatives to have discussions about issues like certificates of a 15 years’ medicine use in EU, the necessary preparation work before registration, European Pharmacopoeia and EU monograph, as well as product catalogue, GMP requirements and costs, etc. The representatives actively participated in the discussion and exchanged ideas with experts. The seminar was warmly accepted by both the EU experts and representatives.
