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Harmonised European Standards as a Basis for the Safe Use of Herbal Medicinal Products and Their Marketing Authorisation in European Union Member States

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Abstract

European Directive 2004/24/EC introduced a simplified registration for traditional herbal medicinal products and a mandate to establish an expert committee at the European Medicines Agency (EMA) to facilitate national procedures via European Union (EU) harmonised standards. Its aim was to contribute to public health with guarantees on quality, safety and appropriate patient information for traditional products that do not require clinical efficacy data compared with new pharmaceutical developments. In this article we review the implementation of the legislation, including the number and type of (i) monographs and guidance documents established at the EMA, and (ii) licensed herbal medicinal products in the EU Member States. Both datasets were compared in order to examine the use of regulatory pathways and harmonised standards. Between 2004 and the end of 2016, about 190 herbal substances have been assessed at European level, leading to 150 monographs, 13 list entries and 19 public statements, as well as general guidance. During that period, 1719 registrations and 859 authorisations have been granted in the EU Member States. Monographs are now largely used in national, and increasingly in European, procedures. Monographs and nationally approved products match principally as regards the main herbal substances and their uses. Specific features of herbal medicinal products are also presented and achievements and remaining gaps are discussed. We conclude that coordinated standards for use in individual product licensing provide a firm reference for assessors and companies, and a reliable evaluation of safe use for patients. After successful establishment of monographs and guidelines, and authorisation of products for the main plants used in Europe, future activities now shift to monograph updates and the evaluation of combinations and substances from non-European traditions.

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Notes

  1. The MRP is based on medicines being evaluated and approved by an RMS followed by a 90-day period where the CMSs consider the RMS assessment report. In the DCP the applications are submitted in parallel to RMS and CMSs. Within 210 days the RMS prepares an assessment and the CMSs consider the RMS assessment report.

  2. The MRI Product Index includes medicines approved in the Member States of the European Union according to the Mutual Recognition or DCP. See also https://mri.cts-mrp.eu/Human/about.

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Acknowledgements

The authors gratefully acknowledge the provision of data by all contact points at 28 EU National Competent Authorities between 2011 and 2017 as well as previous trainees at the secretariat of the HMPC at the EMA, for their patience in collection and compilation of data obtained during annual surveys.

Disclaimer

The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.

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  1. European Medicines Agency, 30 Churchill Place, Canary Wharf, London, E14 5EU, UK

    Wieland Peschel & Beatriz Monedero Alvarez

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  1. Wieland Peschel
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Correspondence to Wieland Peschel.

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Wieland Peschel is an employee of the EMA and Beatriz Monedero Alvarez has been a trainee at the EMA. The authors have no other conflict of interests that are directly relevant to the content of this article.

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Peschel, W., Alvarez, B.M. Harmonised European Standards as a Basis for the Safe Use of Herbal Medicinal Products and Their Marketing Authorisation in European Union Member States. Pharm Med 32, 275–293 (2018). https://doi.org/10.1007/s40290-018-0242-x

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