Masterarbeit

EU Herbal Monographs - chances and limitations in Regulatory Affairs

Sarah Kruck (2018)

Summary
In order to consolidate the heterogeneous regulation of (traditional) herbal medicinal products in the EU Member States, the so called "Herbal Directive" 2004/24/EC came into force in 2004. Among other changes, the concept of EU herbal monographs was introduced which had consequences for marketing authorisations holders of already approved herbal products as well as for new applications, although they are not legally binding. In this thesis, the current regulatory environment concerning EU herbal monographs is evaluated from the perspective of the pharmaceutical industry.
For this purpose, the relevant EU legislation on herbal medicinal products of traditional and well-established use is described. Consequentially, the regulatory guidance and evaluation criteria defined by the HMPC for the development of EU herbal monographs are examined. For analysis of the actual level of implementation of the legislation among the Member States, an overview of the regulatory herbal landscape on the basis of published statistics and international/national databases is provided.
Based on this analysis, the implications of additional proprietary data and consequences for originators are addressed as well. The adoption and revision of EU herbal monographs can have an impact on already registered or authorised herbal medicinal products.
For new applications referring to a finalised EU herbal monograph, a regulatory strategy needs to be prepared. The advantages and disadvantages of different application types are compared in detail, with a focus on WEU and THMP applications and procedure types. The conclusions and relevant aspects for a regulatory strategy are summarised in a checklist.
Ideas for a refinement of the current regulation system of traditional herbal medicinal products are proposed.
Pages: 67, Annexes: pages: 26