2019, Volume 5, Issue 1
Engineering >> 2019, Volume 5, Issue 1 doi: 10.1016/j.eng.2018.11.012
The Globalization of Traditional Medicines: Perspectives Related to the European Union Regulatory Environment
Federal Institute for Drugs and Medical Devices, Bonn 53175, Germany
Next Previous
Abstract
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.
Keywords
Traditional medicine ; Traditional Chinese medicine ; Committee on Herbal Medicinal Products ; Herbal medicines ; Traditional medicines ; Regulation ; Globalization
Figures
Fig. 1
Fig. 2
References
[ 1 ] Lewington A. Plants for people. London: Transworld Publishers Inc.; 2003. link1
[ 2 ] Heinrich M. Ethnopharmazie und Ethnobotanik. Eine Einführung. Stuttgart: Wissenschaftliche Verlagsgesellschaft; 2001. German. link1
[ 3 ] Doull J, Bruce MC. Origin and scope of toxicology. In: Klaassen CD, Amdur MO, Doull J, editors. Casarett and Doull’s toxicology—the basic science of poisons. New York: Macmillan Publishing Company; 1986. p. 3–32. link1
[ 4 ] Gallo MA. History and scope of toxicology. In: Klaassen CD, editor. Casarett and Doull’s toxicology—the basic science of poisons. New York: McGraw Hill Education; 2013. p. 13–48. link1
[ 5 ] World Health Organization. WHO traditional medicine strategy 2014–2023. Geneva: World Health Organization; 2013.
[ 6 ] European Commission [Internet]. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (consolidated version: 16/11/ 2012, amended by Directive 2002/98/EC, Directive 2003/63/EC, Directive 2004/24/EC, Directive 2004/27/EC, and Directive 2008/29/EC). Brussel: European Union; c1995–2018 [cited 2018 Jul 5]. Available from: https://ec. europa.eu/health/documents/eudralex/vol-1_en#dir.
[ 7 ] European Directorate for the Quality of Medicines and Human Health [Internet]. France: Council of Europe; c2018 [cited 2018 Jul 5]. Available from: http://www.edqm.eu.
[ 8 ] European Directorate for the Quality of Medicines and Human Health. European Pharmacopoeia. 9th ed. Strasbourg: EDQM; 2017. link1
[ 9 ] European Medicines Agency [Internet]. London: European Medicines Agency; c1995–2018 [cited 2018 Jul 5]. Available from: http://www.ema.europa.eu/.
[10] European Commission [Internet]. Notice to applicants—procedures for marketing authorisation—marketing authorisation. Brussel: European Union; c1995–2018 [cited 2018 Jul 5]. Available from: https://ec.europa.eu/health/ sites/health/files/files/eudralex/vol-2/vol2a_chap1_en.pdf.
[11] European Commission [Internet]. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Brussel: European Union; c1995–2018 [cited 2018 Jul 5]. Available from: https://ec. europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2004_24/dir_ 2004_24_en.pdf.
[12] Fan TP, Deal G, Koo HL, Rees D, Sun H, Chen S, et al. Future development of global regulations of Chinese herbal products. J Ethnopharmacol 2012;140 (3):568–86. link1
[13] Wiesner J, Knöss W. Future visions for traditional and herbal medicinal products—a global practice for evaluation and regulation? J Ethnopharmacol 2014;158(Part B):516–8. link1
[14] Pelkonen O, Pasanen M, Lindon JC, Chan K, Zhao L, Deal G, et al. Omics and its potential impact on R&D and regulation of complex herbal products. J Ethnopharmacol 2012;140(3):587–93. link1
京公网安备 11010502051620号
