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The European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. It is a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines. These standards apply to medicines for both human and veterinary use.
The European Pharmacopoeia has a legally binding character. It is used as an official reference to serve public health, and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product. The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-eight (38) signatory states, which include all European Union member states.
Several legal texts make the European Pharmacopoeia mandatory in Europe. The Convention on the Elaboration of a European Pharmacopoeia (CETS 50) which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the European Pharmacopoeia. In 1994, a Protocol (ETS No. 134) was adopted, amending the Convention to prepare for the accession of the European Union (EU), and defining the respective powers of the European Union and its Member States within the European Pharmacopoeia Commission.
European Union Directive 2001/82/EC and Directive 2001/83/EC, (as amended) state the legally binding character of European Pharmacopoeia texts for Marketing Authorisation Applications (MAA). All manufacturers of medicines or substances for pharmaceutical use therefore must apply the European Pharmacopoeia quality standards in order to be able to market and use these products in Europe.
As of September 2018, thirty-eight (38) member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. Twenty-eight (28) countries from all continents are part of its observers, as is the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA).
The European Pharmacopoeia CommissionEdit
While the European Directorate for the Quality of Medicines & HealthCare (EDQM), a directorate of the Council of Europe, provides scientific and administrative support for the European Pharmacopoeia, the governing body is the European Pharmacopoeia Commission. The European Pharmacopoeia Commission determines the general principles applicable to the elaboration of the European Pharmacopoeia. It also decides the work programme, sets up and appoints experts to the specialised groups responsible for preparing monographs, adopts these monographs, and recommends dates for the implementation of its decisions within the territories of the contracting parties.
This Commission meets in Strasbourg, France, three times a year, to adopt texts proposed by its groups of experts, and to decide on its programme of work and general policies. Items are added to the work programme in response to requests received by the European Directorate for the Quality of Medicines & HealthCare from the Member States and their national authorities, industry or experts from around the world, based on current scientific and health issues. Each national delegation has one vote. In all technical questions, the decisions of the Commission are taken by a unanimous vote of the national delegations that cast a vote. Member States' representatives mostly come from health authorities, national pharmacopoeia authorities and universities; and are appointed by the national authorities on the basis of their expertise. Representatives of the thirty (30) observers are invited to attend the sessions, but cannot vote.
The current Chair of the Commission is Dr Tobias Gosdschan, who was elected in March 2016. Dr Gosdschan's term for Chair is three years, and runs in parallel with other members of the Commission's Presidium.
The first edition of the European Pharmacopoeia was published in 1969, and consisted of 120 texts. The ninth edition,, currently applicable, was published in July 2016. The Ph. Eur. is applicable in 38 European countries and used in over 100 countries worldwide. Nowadays it contains almost 3000 texts (the monographs), covering all therapeutic areas and consisting of:
- individual texts describing legally-binding quality standards for substances used in the manufacture of medicines or medicine ingredients (including active pharmaceutical ingredients, excipients, herbals, etc.);
- individual texts describing legally-binding quality standards for finished products;
- general monographs describing legally-binding quality standards for classes of substances (such as fermentation products or substances for pharmaceutical use) or for the dosage forms that medicines can take (tablets, capsules, injections, etc.); and
- general methods of analysis of substances used in the manufacture of medicines, which are not legally-binding and may also be used for substances and medicines not described in the Ph. Eur.
Ph. Eur. texts contain detailed analytical methods to identify the substance or product and control its quality and quantitative strength.
Ph. Eur. texts also address the issue of impurities in medicinal products, which do not offer any therapeutic benefit for the patient and sometimes are potentially toxic. Impurities are present at every stage of the manufacture of medicines: in starting materials, active pharmaceutical ingredients (APIs), reagents, intermediates, excipients and primary packaging materials. But the Ph. Eur. texts’s section on impurities is perhaps the most essential part of a quality standard of an active substance.
A new edition of the European Pharmacopoeia is published every three years: in both English and French, by the Council of Europe. It is made available in print and electronic (online and downloadable) versions; the online version is also accessible from smartphones and tablet computers.
Translations into other languages are published by the Member States themselves. For example, a German version is jointly published by Austria, Germany and Switzerland.
- "European Pharmacopoeia (Ph. Eur.) – Background & Mission". www.EDQM.eu. European Directorate for the Quality of Medicines & HealthCare (EDQM). Retrieved 8 November 2016.
- "155th Session of the European Pharmacopoeia Commission (21-22 June 2016)" (pdf). www.EDQM.eu (Press release). Strasbourg, France: European Directorate for the Quality of Medicines & HealthCare (EDQM). 30 June 2016. Retrieved 8 November 2016.
- "Details of Treaty No.050, Convention on the Elaboration of a European Pharmacopoeia". www.CoE.int. Treaty Office, Council of Europe. Retrieved 8 November 2016.
- "Details of Treaty No.134, Protocol to the Convention on the Elaboration of a European Pharmacopoeia". www.CoE.int. Treaty Office, Council of Europe. Retrieved 8 November 2016.
- "Directive 2001/82/EC of the European Parliament and of The Council of 6 November 2001 on the Community code relating to veterinary medicinal products" (pdf). ec.Europa.eu - Official Journal of the European Communities. European Union. 6 November 2001. Retrieved 8 November 2016.
- "Directive 2001/83/EC of the European Parliament and of The Council of 6 November 2001 on the Community code relating to medicinal products for human use" (pdf). Eur-Lex.Europa.eu - Official Journal of the European Communities. European Union. 6 November 2001. Retrieved 8 November 2016.
- "European Pharmacopoeia (Ph. Eur.) 9th Edition". www.EDQM.eu. European Directorate for the Quality of Medicines & HealthCare (EDQM). Retrieved 8 November 2016.
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