In the Member States of the European Union (EU), a harmonized legislation on medicinal products has been enforced, which specifically defines herbal medicinal products and traditional herbal medicinal products. The sc...In the Member States of the European Union (EU), a harmonized legislation on medicinal products has been enforced, which specifically defines herbal medicinal products and traditional herbal medicinal products. The scope was to create a regulatory environment that takes into account the particular characteristics of herbal medicinal products. The harmonization of standards is intended to harmonize assessment and facilitate access to the market in different Member States. The standards defined by the EU herbal monographs of the Committee on Herbal Medicinal Products (HMPC) and the quality requirements laid down in the European Pharmacopoeia represent an excellent model of multinational harmonization of the regulatory environment for herbal and traditional medicines. It has also been demonstrated that this framework is at least partially applicable for herbal and traditional medicines from traditional Chinese medicine (TCM) to gain access to the EU market. Moreover, the HMPC provides specific guidance documents and pilot projects on monographs on the safety and efficacy of Chinese herbal drugs. In the European Pharmacopoeia, the number of quality monographs of herbal drugs with an origin in TCM is continuously growing. These developments indicate that globalization of traditional medicines is an ongoing process. Communication and cooperation between regulators, the scientific community, and interested stakeholders will set the stage for the convergence of diverse regulatory environments. This will contribute to worldwide availability of traditional medicines based on appropriate standards.展开更多
Ladies and gentlemen, it is a great pleasure for me to be here to thank DIA and also CPA for inviting me and having this very interesting workshop with many people around the world, who are especially from EU and Chin...Ladies and gentlemen, it is a great pleasure for me to be here to thank DIA and also CPA for inviting me and having this very interesting workshop with many people around the world, who are especially from EU and China, and are experts on herbal and traditional medicines. And all I am going to do is just using 30 minutes to give you an overview on the regulatory framework existing in the European Union.展开更多
IMPACT OF BREXIT ON CHINESE COMPANIES' ACCESS TO THE EUROPEAN MARKET Q: We have a product, which was approved in UK in 2017. Now we want to expand the market to the Europe. Do you have any suggestions about which ...IMPACT OF BREXIT ON CHINESE COMPANIES' ACCESS TO THE EUROPEAN MARKET Q: We have a product, which was approved in UK in 2017. Now we want to expand the market to the Europe. Do you have any suggestions about which country is easier to accept traditional Chinese medicine?展开更多
文摘In the Member States of the European Union (EU), a harmonized legislation on medicinal products has been enforced, which specifically defines herbal medicinal products and traditional herbal medicinal products. The scope was to create a regulatory environment that takes into account the particular characteristics of herbal medicinal products. The harmonization of standards is intended to harmonize assessment and facilitate access to the market in different Member States. The standards defined by the EU herbal monographs of the Committee on Herbal Medicinal Products (HMPC) and the quality requirements laid down in the European Pharmacopoeia represent an excellent model of multinational harmonization of the regulatory environment for herbal and traditional medicines. It has also been demonstrated that this framework is at least partially applicable for herbal and traditional medicines from traditional Chinese medicine (TCM) to gain access to the EU market. Moreover, the HMPC provides specific guidance documents and pilot projects on monographs on the safety and efficacy of Chinese herbal drugs. In the European Pharmacopoeia, the number of quality monographs of herbal drugs with an origin in TCM is continuously growing. These developments indicate that globalization of traditional medicines is an ongoing process. Communication and cooperation between regulators, the scientific community, and interested stakeholders will set the stage for the convergence of diverse regulatory environments. This will contribute to worldwide availability of traditional medicines based on appropriate standards.
文摘Ladies and gentlemen, it is a great pleasure for me to be here to thank DIA and also CPA for inviting me and having this very interesting workshop with many people around the world, who are especially from EU and China, and are experts on herbal and traditional medicines. And all I am going to do is just using 30 minutes to give you an overview on the regulatory framework existing in the European Union.
文摘IMPACT OF BREXIT ON CHINESE COMPANIES' ACCESS TO THE EUROPEAN MARKET Q: We have a product, which was approved in UK in 2017. Now we want to expand the market to the Europe. Do you have any suggestions about which country is easier to accept traditional Chinese medicine?
