Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Impact of the Implementation of Directive 2004/24/EC: Development of Marketing Authorisations for Herbal Medicinal Products and Registrations for Traditional Herbal Medicinal Products in Germany in the European Regulatory Environment ***

Alexandra Scheibe geb. Kürzel (Abschlußjahr: 2013)

Language: English
Directive 2004/24/EC [11] is a milestone for herbal medicines in the European pharmaceutical legislation process. The objective was to harmonise the national laws of the Member States in order to protect public health since in the past the guarantees of quality, safety and efficacy were not equally provided among the Member States [22]. That is particularly demonstrated by the establishment of the HMPC as part of the EMA having regard to the particularities of HMPs and THMPs in the European Community and the introduction of a simplified TU registration procedure for THMPs by Directive 2004/24/EC [11].
The implementation of Directive 2004/24/EC [11] by the 14th Act Amending the Drug Law of 5 September 2005 [18] has led to a particular situation for herbal medicines in Germany because a nationally regulated market for herbal medicines has already been established in German legislation since 1978 [20][21].
In this context, the impact of Directive 2004/24/EC [11] on different regulatory criteria for HMPs and THMPs in Germany was investigated (the development of WEU and TU applications, the development of the use of NPs, MRPs and DCPs, the involvement of Germany as RMS/CMS in MRPs and DCPs and the relevance of HMPC monographs). A comprehensive presentation of data research on the regulatory development of herbal medicines in Germany between 1978 and 2012 is provided. The data for this research were obtained from the Drug Information System (AMIS) database and from the evaluation of an annual questionnaire prepared by the BfArM on request of the EMA. The data provided are not fully available as such from public sources.
The high appreciation of HMPs and THMPs was demonstrated by a total of 439 applications for TU registrations in accordance with Section 39 a-d AMG and 141 (14) AMG [18] and of 358 applications for WEU marketing authorisations in accordance with Section 22 (3) AMG [18] between 2005 and 2012.
The acceptance and relevance of WEU and TU monographs established by the HMPC as an instrument for the harmonised evaluation in applications for WEU marketing authorisations and TU registrations, is an important result of Directive 2004/24/EC [11] in Germany. Out of all HMPC monographs, about 80% include a TU while about 20% include a WEU [16].
Due to the current development of TU registrations and the on-going preparation of TU monographs by the HMPC, an increase of the relevance of TU registration applications might be expected in Germany.
A further impact of Directive 2004/24/EC [11] is the adaptation of TMPs which have already been authorised in the German legislation in the “revision of the old market process” with the European requirements of Directive 2004/24/EC [11].
A strong preference for using the NP by pharmaceutical companies in order to gain access to the German market was also shown. The MRPs were used to minor extent so far while the DCPs was used to greater extent for submitting WEU applications [11]. It was further demonstrated that in all applications via DCPs for herbal medicines in which Germany was involved, Germany acted as RMS. Moreover, the first DCP of an application for a TU registration in which Germany acts as RMS is under evaluation, currently.
For the majority of criteria investigated, a final statement on the impact of Directive 2004/24/EC cannot be given so far due to the fact that Directive 2004/24/EC has not been in force for a sufficiently long period of time.
However, the current development of the individual criteria (the use of TU applications, the use of DCPs, the involvement of Germany as RMS in DCPs and the use of TU monographs) suggests increasing the impact of Directive 2004/24/EC [11] on these criteria in Germany. Due to the nationally regulated market for HMPs in Germany this impact might be supported by the long- term experience in regulatory and scientific handling of HMPs by the BfArM and pharmaceutical companies in order to achieve a harmonised market for herbal medicines on European level.
However, it will probably take at least a decade to transfer this legislation to the market situation in Germany. Thus, it has to be taken into account that the process is still on-going and further impacts shall be analysed in the future.
Pages: 54