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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.
Contents
Legal basis
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 Application (MAA) for a medicinal (human or veterinary) product. Pharmacopoeia Europaea quality standards 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 and the 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 November 2016, thirty-seven (37) member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. Twenty-six (26) 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 Commission
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 time limits 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, based on current scientific and health issues in Europe. 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 are from health authorities, national pharmacopoeia authorities, universities or industry; and are appointed by the national authorities on the basis of their expertise. Representatives of the twenty-eight (28) 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 term for Chair is three years, and runs in parallel with other members of the Commission's Presidium.
Publication
The 1st Edition of the European Pharmacopoeia was published in 1969, and comprised 120 texts. The 9th Edition, was published in July 2016 and is currently in force. It contains some 2,300 monographs, and more than 350 general chapters, illustrated with diagrams or chromatograms, and over 2,500 descriptions of reagents. With 121 new and 1,403 revised texts, over 50 percent of the 9th Edition's content is new compared to the 8th Edition. It consists of three initial volumes (9.0), and will culminate in a collection of eight non-cumulative supplements (9.1 to 9.8).
A new edition 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 downladable) 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.