European Pharmacopoeia
The European Pharmacopoeia (Pharmacopoeia Europaea, Ph. Eur.) is a pharmacopoeia that aims to provide common quality standards throughout Europe to control the quality of medicines and the substances used to manufacture them. It is a published collection of monographs that 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 Ph. Eur. 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 product. Ph. Eur. quality standards apply throughout the entire life-cycle of a product and become legally binding and mandatory on the same date in all 37 signatory states and the European Union member states.
Several legal texts make the Ph. Eur. mandatory in Europe. The Convention on the Elaboration of a European Pharmacopoeia (CETS 50) [1] which was adopted by the Council of Europe in 1964, laid the groundwork for the development of the Ph. Eur. In 1994, a Protocol (ETS No. 134) [2] was adopted amending the Convention to prepare for the accession of the European Union and defining the respective powers of the European Union and its Member States within the Ph. Eur. Commission.
European Union directives (2001/82/EC [3] and 2001/83/EC,[4] as amended, and 2003/63/EC [5]) state the legally binding character of Ph. Eur. texts for Marketing Authorisation Applications (MAA). All manufacturers of medicines or substances for pharmaceutical use therefore must apply the Ph. Eur. quality standards in order to be able to market and use these products in Europe.
As of December 2012, 37 member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. Twenty-six 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 administrative and scientific support for the Ph. Eur., the governing body is the Ph. Eur. Commission. The Ph. Eur. Commission determines the general principles applicable to the elaboration of the Ph. Eur. 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 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 EDQM 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 come 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 26 observers are invited to attend the sessions, but cannot vote.
The current Chair of the Commission is Dr Jean-Louis Robert, who has been elected for three years (from June 2013 to June 2016).
Publication
The 1st Edition of the Ph. Eur. was published in 1969 and comprised 120 texts. The 8th Edition, published in July 2013 and is currently in force, contains more than 2220 monographs and 340 general chapters illustrated with diagrams or chromatograms and over 2500 descriptions of reagents. It consists of two initial volumes (8.0), with an implementation date of January 1, 2014. Volume 1 contains introductory information, general chapters and reagents, as well as monographs grouped by theme (dosage forms, vaccines, plants, etc.). Volume 2 contains all other monographs as well as an index of the entire contents of the Ph. Eur.. The 8th Edition will culminate in a collection of eight non-cumulative supplements (8.1 to 8.8).
A new edition is published every three years. It is made available in print and electronic (online and USB stick) versions, in both English and French by the Council of Europe. The online version is also accessible from smartphones and tablet computers.
Translations into other languages are published by the member states themselves e.g. a German version is jointly elaborated by Austria, Germany and Switzerland.
