08 May Austria one of top reference member states for EU procedures with (traditional) herbal medicinal products
After an initial reluctance European authorisation and registration procedures are increasingly used also for (traditional) herbal medicinal products. Austria is a requested reference member state for such procedures and currently number two in the EU-ranking of RMS.
With the start of the work of the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA) in 2004 a successful approach towards harmonisation of (traditional) herbal medicinal products in the EU started. Corner stones for a harmonised view on efficacy and safety are the European Union monographs established by the HMPC. Meanwhile more than 150 monographs are published, where Austria also played an important role as rapporteur and peer reviewer (14 monographs finalised, 1 draft, 3 revisions, 13 peer reviews).
Based on such monographs meanwhile in total 82 European procedures (DCP, MRP) concerning (traditional) herbal medicinal products are finalised in the EU. Austria acted in 15% as RMS. In the EU-ranking is this number 2 behind Germany (54% of all procedures) and before Belgium (app. 10%). Out of the 28 member states only 11 acted as RMS so far. Although such procedures are still a great challenge to the small team of assessors in Austria the work is acknowledged as ongoing contribution to a harmonisation in the EU. European procedures are currently predominately used for bibliographic applications according to Article 10a of Dir. 2001/83 as amended, currently only about 20% of the procedures concerned traditional herbal medicinal products according to Article 16a. Although many European Union monographs are not endorsed from all member states all procedures with Austria as RMS were finalised positively. Applicants are advised to contact the HMPC secretariat if they want more information regarding the voting outcome on monographs for the planning of potential CMS.
While European Union monographs are considered as guidance documents the so-called ‘List entries’ for herbal preparations without any safety concern are legally binding. In a registration procedure no additional data regarding safety, evidence of traditional use and plausibility of efficacy may be requested. This list, published by the European Commission, comprises currently 11 herbal preparations. However, none of these were used for a European registration procedure so far.
In case of scientific questions ahead of the start of a procedure the Austrian agency offers national scientific advice.
Originally published on the homepage of AGES under http://www.basg.gv.at/en/news-center/uptodate-newsletter/uptodate-issues-2016/uptodate-ausgabe-35/#ce-newsletter-16513
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