Masterarbeit

Opportunities for simplified registration of herbal medicinal products with limited clinical data in selected Non-EU countries ***

Sandra Eikermann (2020)

Summary
Language: English
In the European Union (EU) herbal medicinal products require a marketing authorization, before they can legally be marketed. Besides the application of a conventional full marketing authorization according to Art. 8(3) of Directive 2001/83/EC, for which the applicant needs to generate extensive preclinical and clinical data, the registration of herbal medicinal products in the EU is also possible via procedures, which do not necessarily require company´s own studies, i.e. there is a simplification concerning clinical and preclinical documentation. According to Art. 10a of Directive 2001/83/EC the applicant has the possibility to submit a well-established use marketing authorization application for products with a well-established use within the EU for the last ten years. Further simplification is given for herbal medicinal products with a long tradition not fulfilling the requirements for an application for marketing authorization according to Art. 8(3) or 10a of Directive 2001/83/EC by a traditional use registration application according to Art 16a of Directive 2001/83/EC, which requires the evidence of a medicinal use throughout a period of at least 30 years, including at least 15 years in the EU. References to European herbal monographs covering a well-established or traditional use for herbal substances or preparations are also possible. As clinical investigation requires the expenditure of considerable time, personal resources and money, simplified registration of medicinal products is especially interesting for Small and Medium Enterprises (SME), as they have not the same financial and personal resources as large companies do. For pharmaceutical companies intending the Non-EU internationalization of their herbal medicinal products, which have gone through a simplified registration procedure in the EU, information about availability of simplified procedures in relevant markets is of particular importance for evaluating their chances of market entry. In this thesis the opportunities for simplified registration of herbal medicinal products in Argentina, Australia, Brazil, Switzerland and South Africa are evaluated. For each of the analyzed countries a specific regulation for herbal medicinal products could be identified which includes a simplified registration. The simplified registration procedures are partly similar to the legislation of the European Union, but still differ. A legislation about the implementation of simplified registration based on well-established and traditional use was found outside the EU. Simplified registration which refer to monographs, such as EU herbal monographs, is also available. Furthermore, some special simplified regulations could be identified. There are countries, which lean on assessment reports of foreign authorities (including regulatory bodies that are located within the EU) and others who accept only simple notification without any assessment by a regulatory authority before market entry.
Pages: 58