Eur., the EDQM also develops guidance and standards in areas such as blood transfusion, organ, tissue and cell transplantation and consumer health issues. In addition to the work related to the Ph. Hence, companies must follow these standards when applying to a national competent authority or the European Medicines Agency (EMA) for a marketing authorisation and must include reference to the monographs in the quality part of their application dossiers.
All medicines marketed in the signatory states of the Convention, together with their components, must comply with the quality standards of the Ph. are recognised as a scientific benchmark world-wide. In addition, the observers of the European Pharmacopeia Commission (currently 7 European and 17 non-European countries, as well as the WHO and the Taiwan Food and Drug Administration) can benefit from this European experience in work-sharing and harmonisation and have access to the scientific work on the quality control of medicines. It is legally binding in the 38 signatory parties of the Convention: 37 member states and the European Union. Eur.) provides a legal and scientific reference for the quality control of medicines. Bouin).ĭeveloping quality standards for medicines, supporting their implementation and monitoring their application. Eur., European Pharmacopoeia EU, European Union EMA, European Medicines Agency HMPC, EMA's Committee on Herbal Medicinal Products CRS, Chemical Reference Substance HRS, Herbal Reference Standard n Corresponding author. This is achieved byĪbbreviations: CoE, Council of Europe EDQM, European Directorate for the Quality of Medicines and HealthCare Ph. The EDQM's mission is to protect public health and to contribute to equal access to good quality medicines and healthcare – a basic human right for all of Europe's citizens. The European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the CoE, is based on the Convention on the elaboration of a European Pharmacopoeia, which was adopted in 1964 to harmonise quality standards for medicinal substances that in their original state or in the form of pharmaceutical preparations are of general interest and importance to the people of Europe. The CoE's main aim is to create a common democratic and legal area throughout the European continent, ensuring respect for its fundamental values: human rights, pluralist democracy and the rule of law. Its headquarters are located in Strasbourg, France. European Directorate for the Quality of Medicines and HealthCare Founded in 1949, the Council of Europe (CoE) is the oldest panEuropean organisation, which today has 47 member states, representing 820 million European citizens. Keywords: Quality control Regulatory affairs European Pharmacopoeia Monographs Herbal drugsġ. collaborate in many areas with the European Medicines Agency (EMA) to ensure close collaboration as regards the respective work programmes and approach.
Screening methods for aristolochic acids are applied for herbal drugs that may be subject to adulteration or substitution with plant material containing aristolochic acids. also provides general methods including methods for determination of aflatoxins B1 and ochratoxin A. Criteria for pesticides and heavy metals for example are defined in the general monograph on Herbal drugs. Materials and methods: The requirements for a specific herbal drug are prescribed in the corresponding individual monograph and the relevant general monographs. It is legally binding in the 38 signatory parties of the Convention on the elaboration of a European Pharmacopoeia (37 member states and the European Union). Quality standards of the European Pharmacopoeia Anne-Sophie Bouin n, Michael Wierer European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe, 7 Allée Kastner, Cs 30026, F-67081 Strasbourg, FranceĪrticle history: Received 25 March 2014 Received in revised form Accepted 8 July 2014Įthnopharmacological relevance: The European Pharmacopoeia (Ph. Journal of Ethnopharmacology journal homepage: Research Paper Journal of Ethnopharmacology ∎ (∎∎∎∎) ∎∎∎–∎∎∎Ĭontents lists available at ScienceDirect
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