Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Phytopharmaceuticals: Analysis of the authorised landscape in the EU and resulting submission opportunities and challenges from the view of a SME ***

Lucille Küng (Abschlußjahr: 2015)

Summary
The likelihood of a positive outcome for herbal well-established use (WEU) marketing authorisation or traditional-use registration (TUR) applications is not only influenced by the overall quality of the dossier submitted by an applicant, but is also a function of the involved competent authority’s assessment practices. Thus, differences in assessment practices between competent authorities can require highly diverging resources on behalf of the applicant. Especially for micro, small and medium-sized enterprises (SMEs), cost and risk control is vital and the restricted resources available to deal with concerns raised by a competent authority can turn out to be a limiting factor. Hence, it is indispensable to thoroughly assess the regulatory opportunities and risks associated with a particular country, or combination of countries in case of mutual recognition or decentralised procedures, when determining the strived for market presence.
To gather current information about human herbal medicinal products authorised according to mutual recognition or decentralised procedures, different queries were performed in the MRI Product Index database for human medicinal products on the website of the Heads of Medicines Agencies. Additionally, the eight reports on the uptake of the traditional use registration scheme in the European Union which have so far been published by the Committee on Herbal Medicinal Products, covering the timeframe from national implementation of Directive 2004/24/EC until the end of December 2014, were used to obtain data yielding a basis for deciding on a submission strategy.
Therefore, this thesis aims at determining the best choice of countries most likely to issue a positive decision within a reasonable timeframe while still presenting with a low risk profile as a function of  the dossier available for submission (WEU or TUR) and the number of active substances (monocomponent or combination) presented in a herbal medicinal product from the rather conservative view of a SME.
Pages: 87, Annexes: 4, pages: 13