Quality standards of the European Pharmacopoeia

doi:10.1016/j.jep.2014.07.020

Journal of Ethnopharmacology

Volume 158, Part B, 2 December 2014, Pages 454-457

https://doi.org/10.1016/j.jep.2014.07.020 Get rights and content

Abstract

Ethnopharmacological relevance: The European Pharmacopoeia (Ph. Eur.) provides a legal and scientific reference for the quality control of medicines. 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).

Materials and methods: The requirements for a specific herbal drug are prescribed in the corresponding individual monograph and the relevant general monographs. Criteria for pesticides and heavy metals for example are defined in the general monograph on Herbal drugs. The Ph. Eur. also provides general methods including methods for determination of aflatoxins B1 and ochratoxin A. Screening methods for aristolochic acids are applied for herbal drugs that may be subject to adulteration or substitution with plant material containing aristolochic acids.

Conclusion: The Ph. Eur. collaborate in many areas with the European Medicines Agency (EMA) to ensure close collaboration as regards the respective work programmes and approach.

Graphical abstract

Section snippets

European Directorate for the Quality of Medicines and HealthCare

Founded in 1949, the Council of Europe (CoE) is the oldest pan-European organisation, which today has 47 member states, representing 820 million European citizens. Its headquarters are located in Strasbourg, France. 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.

The European Directorate for the Quality of Medicines and HealthCare (EDQM), a

Portfolio of monographs and general chapters for herbals

About 12% of the Ph. Eur. texts are directly related to herbals. The Ph. Eur. contains general monographs on herbal drugs and herbal drug preparations (e.g. “Herbal teas”, “Extracts”, “Essential oils Ph. Eur., 2013), as well as an increasing number of monographs on specific herbals. In 2013, it included 187 monographs on herbal drugs (e.g. “Melissa leaf”, “Liquorice root” (Ph. Eur., 2013) – including 40 monographs on herbal drugs used in Traditional Chinese Medicine – and 85 monographs on

Reference standards of the European Pharmacopoeia

Pharmacopoeial monographs require the use of different reference materials as benchmarks for analytical testing. These reference materials can be classified according to their intended use, i.e. both qualitative (for the purpose of screening for adulterants or for peak identification and system suitability test in chromatography) and quantitative (assigned content).

In the field of herbals, the Ph. Eur. establishes the following types of reference standards:

•
Chemical reference substances (CRS) of

Interactions between the EDQM and regulators

Since 1975, the EU pharmaceutical legislation makes direct reference to the Ph. Eur. Today, it also refers to other activities under the EDQM׳s responsibility, such as the procedure for certification of suitability to the monographs of the European Pharmacopoeia and co-ordination of the European network of Official Medicines Control Laboratories.

While the Council of Europe is distinct from the European Union and its institutions, the two organisations collaborate in many areas. The EMA׳s

Conclusions

In summary, the Ph. Eur. provides legally binding standards for a vast array of health-related products, including for herbal drugs and herbal drug preparations. It has to address public health issues, to regularly update analytical methods to ensure alignment with the current state of scientific knowledge and to establish and supply appropriate reference materials. Finally, particular attention is given to maintaining a close relationship with manufacturers, regulatory authorities, the HMPC

References (3)

Ph.Eur 8th Edition. Strasbourg, France: Council of Europe; 20 (vol 1);...

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Research PaperQuality standards of the European Pharmacopoeia