The ''European Pharmacopoeia'' (''Pharmacopoeia Europaea'', ''Ph. Eur.'') is a major regional

pharmacopoeia A pharmacopoeia, pharmacopeia, or pharmacopoea (or the typographically obsolete rendering, ''pharmacopœia''), meaning "drug-making", in its modern technical sense, is a reference work containing directions for the identification of compound med ...

which provides common quality standards throughout the

pharmaceutical industry The pharmaceutical industry is a medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or self-administered by) patients for curing ...

Europe Europe is a continent located entirely in the Northern Hemisphere and mostly in the Eastern Hemisphere. It is bordered by the Arctic Ocean to the north, the Atlantic Ocean to the west, the Mediterranean Sea to the south, and Asia to the east ...

to control the quality of

medicines Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the ...

, and the substances used to

manufacture Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of the secondary sector of the economy. The term may refer to a r ...

them. It is a published collection of

monograph A monograph is generally a long-form work on one (usually scholarly) subject, or one aspect of a subject, typically created by a single author or artist (or, sometimes, by two or more authors). Traditionally it is in written form and published a ...

s which describe both the individual and general quality standards for ingredients,

dosage form Dosage forms (also called unit doses) are pharmaceutical drug products presented in a specific form for use. They contain a mixture of active ingredients and inactive components ( excipients), configured in a particular way (such as a capsule she ...

s, and methods of

analysis Analysis (: analyses) is the process of breaking a complex topic or substance into smaller parts in order to gain a better understanding of it. The technique has been applied in the study of mathematics and logic since before Aristotle (38 ...

for medicines. These standards apply to medicines for both

human Humans (''Homo sapiens'') or modern humans are the most common and widespread species of primate, and the last surviving species of the genus ''Homo''. They are Hominidae, great apes characterized by their Prehistory of nakedness and clothing ...

and

veterinary Veterinary medicine is the branch of medicine that deals with the prevention, management, diagnosis, and treatment of disease, disorder, and injury in non-human animals. The scope of veterinary medicine is wide, covering all animal species, both ...

use.

Legal basis

The ''European Pharmacopoeia'' has a

legally binding In law, liable means "responsible or answerable in law; legally obligated". Legal liability concerns both civil law and criminal law and can arise from various areas of law, such as contracts, torts, taxes, or fines given by government agenci ...

character. It is used as an official reference to serve

public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the de ...

, and is part of the regulatory requirements for obtaining a

Marketing Authorisation Marketing authorisation is the process of reviewing and assessing the evidence to support a medicinal product, such as a drug, in relation to its marketing, finalised by granting of a licence to be sold. This process is performed within a legal f ...

(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-nine (39) signatory states, which include all

European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...

member states. Several

legal Law is a set of rules that are created and are law enforcement, enforceable by social or governmental institutions to regulate behavior, with its precise definition a matter of longstanding debate. It has been variously described as a Socia ...

texts make the ''European Pharmacopoeia'' mandatory in . The Convention on the Elaboration of a European Pharmacopoeia (ETS No. 50) which was adopted by the

Council of Europe The Council of Europe (CoE; , CdE) is an international organisation with the goal of upholding human rights, democracy and the Law in Europe, rule of law in Europe. Founded in 1949, it is Europe's oldest intergovernmental organisation, represe ...

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 A member state is a state that is a member of an international organization or of a federation or confederation. Since the World Trade Organization (WTO) and the International Monetary Fund (IMF) include some members that are not sovereign 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 Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...

use therefore must apply the ''European Pharmacopoeia'' quality standards in order to be able to market and use these products in Europe. As of February 2020, thirty-nine (39) member states and the

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 The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...

(WHO) and the Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare.

The European Pharmacopoeia Commission

While the

European Directorate for the Quality of Medicines & HealthCare The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the ''Convention on the Elaboration of a European Pharmacopoeia'' ...

(EDQM), a directorate of the

, 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 Strasbourg ( , ; ; ) is the Prefectures in France, prefecture and largest city of the Grand Est Regions of France, region of Geography of France, eastern France, in the historic region of Alsace. It is the prefecture of the Bas-Rhin Departmen ...

, 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 A university () is an educational institution, institution of tertiary education and research which awards academic degrees in several Discipline (academia), academic disciplines. ''University'' is derived from the Latin phrase , which roughly ...

; 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. The term of the chair is three years, and runs in parallel with other members of the commission's Presidium.

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. Nowadays it contains over 3000 texts (the

s), 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, by the

. It is made available in print and electronic (online and downloadable) versions; the online version is also accessible from

smartphone A smartphone is a mobile phone with advanced computing capabilities. It typically has a touchscreen interface, allowing users to access a wide range of applications and services, such as web browsing, email, and social media, as well as multi ...

s and

tablet computer A tablet computer, commonly shortened to tablet, is a mobile device, typically with a mobile operating system and touchscreen display processing circuitry, and a rechargeable battery in a single, thin and flat package. Tablets, being computers ...

s. Translations into other languages are published by the member states themselves. For example, a German version is jointly published by Austria, Germany and Switzerland. In the future, the former three-year cycle comprising one edition and eight supplements will be replaced by an annual edition made up of three issues, numbered .1 to .3 (for example, the 12th Edition will consist of issues 12.1, 12.2 and 12.3). Each of these issues will contain the new and revised texts adopted at one of the three European Pharmacopoeia Commission (EPC) sessions held annually. What will not change is the implementation schedule, which remains January, April and July, respectively, of the year following publication of a tex

References

External links

European Directorate for the Quality of Medicines & HealthCare (EDQM Council of Europe)
— official website
European Pharmacopeia 10th EditionCouncil of Europe

— the executive of the

(EU)
European Medicines Agency (EMA)

– European Union Law {{Authority control Pharmacopoeias Law in Europe

Legal basis

The European Pharmacopoeia Commission

Publication

See also

References

External links