European Pharmacopoeia
The European Pharmacopoeia
Legal basis
The European Pharmacopoeia has a legally binding character. It is used as an official reference to serve public health,[1] and is part of the regulatory requirements for obtaining a Marketing Authorisation (MA) for a medicinal (human or veterinary) product.[1] 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-nine (39) signatory states, which include all European Union member states.
Several
European Union Directive 2001/82/EC
As of February 2020, thirty-nine (39) member states and the European Union are signatories to the Convention on the Elaboration of a European Pharmacopoeia. There are 30 observers in all: five European countries, 23 non-European countries, the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare.
The European Pharmacopoeia Commission
While the
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 Prof. Salvador Cañigueral, elected in March 2022.[6] The term of the Chair is three years, and runs in parallel with other members of the commission's Presidium.[6]
Publication
The first edition of the European Pharmacopoeia was published in 1969, and consisted of 120 texts. The 11th edition, currently applicable, was published in July 2022. The Ph. Eur. is applicable in 39 European countries and used in over 130 countries worldwide.[7] Nowadays it contains over 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 Ph. Eur. texts’ 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,[7] 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.[7]
Translations into other languages are published by the member states themselves. For example, a German version is jointly published by Austria, Germany and Switzerland.
See also
References
- ^ a b c d e f g h i "European Pharmacopoeia - Background and Mission - European Directorate for the Quality of Medicines & HealthCare - EDQM". European Directorate for the Quality of Medicines & HealthCare. Retrieved 21 April 2023.
- ^ "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.
- ^ a b "Ph. Eur. Commission elects its new Chair at 172nd Session - European Directorate for the Quality of Medicines & HealthCare - EDQM". European Directorate for the Quality of Medicines & HealthCare. Retrieved 21 April 2023.
- ^ a b c "European Pharmacopoeia (Ph. Eur.) 11th Edition - European Directorate for the Quality of Medicines & HealthCare - EDQM". European Directorate for the Quality of Medicines & HealthCare. Retrieved 21 April 2023.
External links
- European Directorate for the Quality of Medicines & HealthCare (EDQM Council of Europe) — official website
- Council of Europe
- European Commission — the executive of the European Union (EU)
- European Medicines Agency (EMA) Archived 26 May 2012 at the Wayback Machine
- EUR-Lex – European Union Law