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The Globalization of Traditional Medicines: Perspectives Related to the European Union Regulatory Environment

Engineering 2019年第1期5卷 22-31页

作者： Werner Knoess jacqueline wiesner Federal Institute for Drugs and Medical Devices Bonn 53175 Germany

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.

关键词： Traditional medicine Traditional Chinese medicine Committee on Herbal Medicinal Products Herbal medicines Traditional medicines Regulation Globalization

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