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51-654: 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 (an international treaty adopted by the Council of Europe in 1964: ETS 50, Protocol). The signatories to the convention, – 39 member states and

102-624: A European Donation Day (EDD) together with a different member state every year, to raise awareness of the importance of organ donation and transplantation in its member states and to encourage public debate and reflection on this life-saving therapy. Since 1 January 2009, the EDQM has worked on strengthening consumer health protection in Europe, with a focus on the safe use and quality of cosmetics and materials and articles in contact with foodstuffs. The European Committee on Cosmetics and Consumer Health (CD-P-COS)

153-450: A broader meaning: a non-serial publication complete in one volume (book) or a definite number of books. Thus it differs from a serial or periodical publication such as a magazine , academic journal , or newspaper . In this context only, books such as novels are considered monographs. In biological taxonomy , a monograph is a comprehensive treatment of a taxon in written form. Monographs typically review all known species within

204-532: A considerable impact on national mortality and morbidity rates . Therefore, the safe and appropriate use of medicines, which depends on the right information being available to those that need it, is as important as product quality. In order to face this challenge while taking into account current constraints on public health budgets and social inequality in access to healthcare, the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH), which

255-498: A group, add any newly discovered species, and collect and synthesize available information on the ecological associations, geographic distributions, and morphological variations within the group. The first-ever monograph of a plant taxon was Robert Morison 's 1672 Plantarum Umbelliferarum Distributio Nova , a treatment of the Apiaceae . Book publishers use the term "artist monograph" or "art monograph" to indicate books dealing with

306-419: A manufacturer or distributor result in an product whose quality complies with the requirements laid down in the corresponding Ph. Eur. monograph(s) . The EDQM also runs an inspection programme for CEP-holders, targeting their manufacturing and/or distribution sites. The Certification procedure is not compulsory: it is a service that is offered to manufacturers who can submit their CEP in the quality section of

357-407: A monograph is to present primary research and original scholarship. This research is presented at length, distinguishing a monograph from an article. For these reasons, publication of a monograph is commonly regarded as vital for career progression in many academic disciplines. Intended for other researchers and bought primarily by libraries, monographs are generally published as individual volumes in

408-665: A new marketing authorisation (MA) application or a variation of an existing MA . It serves to centralise the evaluation of data for the benefit of both regulatory authorities and industry, thus saving time and resources. A further advantage of the Certification procedure is that it provides the Ph. Eur. Commission with up-to-date information on the quality of substances on the European market, highlighting where Ph. Eur. texts and quality requirements might require revision and helping to ensure that

459-635: A new development, dealing with an activity that had always been a mainstream intergovernmental activity but was relegated to a partial agreement to avoid it being axed altogether. The Venice Commission is unique as being the one agreement which began life as a partial agreement and, being of its success, had to drop the qualifier 'Partial', when the last remaining member state decided to join up. The Council of Europe treaty office issues regularly updated information on all partial and enlarged agreements, listing all member states, observers, dates of accession and reference texts. Polakiewicz, J.: Treaty making in

510-436: A scientific benchmark in the field of quality control for human and veterinary medicines. These common harmonised quality standards – known as monographs – describe strict specifications for medicines and the substances used in their manufacture, that apply throughout the product's entire life cycle. When adopted, they are legally binding and become mandatory on the same date in the 39 European countries that are signatories to

561-587: A short print run . In Britain and the U.S., what differentiates a scholarly monograph from an academic trade title varies by publisher, though generally it is the assumption that the readership has not only specialised or sophisticated knowledge but also professional interest in the subject of the work. A written monograph is usually a specialist book on one topic, although its meaning has been broadened to include any works which are not reference works and which may be written by one or more authors, or an edited collection. In library cataloguing , monograph has

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612-416: A significant shift from medicines on the market testing to the analysis of falsified and illegal medicines on behalf of other authorities such as customs, police, enforcement/food inspectors and courts. The EDQM is responsible for co-ordinating the network's technical activities and ensuring the smooth running of its various joint programmes. The OMCL Network performs studies on medicinal products already on

663-420: A single artist, as opposed to broader surveys of art subjects. The term monograph is also used for audiovisual or film documentary-type representations of a subject, often creatively expressed. The term "monographic film" has also been used for short fiction or animated films. Video or film essays on a single topic are also referred to as monographs. IndyVinyl , by Scottish film academic Ian Garwood,

714-564: Is a monographic research project focused on "vinyl records in American independent cinema between 1987 and 2018". It includes an 8,000-word peer-reviewed academic book chapter; video compilations; "critical montages "; and a series of social media posts, all curated on a website. Garwood has written that his project is "an attempt to produce a research output equivalent to an academic monograph, but incorporating video-based forms of criticism that have been popularised through online film culture". In

765-852: Is also involved in a number of international collaboration and harmonisation initiatives, such as the Pharmacopoeial Discussion Group (PDG), the International Pharmaceutical Regulators Programme (IPRP), the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the International Meeting of World Pharmacopoeias (IMWP), the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) and

816-409: Is co-ordinated by the EDQM, oversees the work of experts in three main areas: The work of the EDQM in the area of blood transfusion is co-ordinated by the European Committee on Blood Transfusion (CD-P-TS), which consists of representatives from authorities working in the field of blood transfusion or at national blood establishments (BEs) from member states of the council of Europe and observers such as

867-424: Is fulfilled by improving and promoting strict standards for quality and safety in order to protect not only the donor and recipient, but also the precious donated organ/tissue itself. The European Committee on Organ Transplantation (CD-P-TO) is the steering committee in charge of transplantation activities). This committee consists of representatives from member states of the Council of Europe, and observers including

918-502: Is recognised as a scientific benchmark worldwide and is legally binding in member states. The EU pharmaceutical legislation refers directly to the Ph. Eur. and to other activities for which the EDQM is responsible (e.g. the Certification procedure or "CEP" and the OMCL Network – see below), demonstrating the shared commitment of the European organisations to public health protection. The EDQM

969-418: Is tasked with developing and strengthening harmonised measures that supplement EU and national legislation to ensure the safety of packaging, containers, utensils and other materials and articles for food contact. It is supported by two subordinate bodies: the working group on food contact materials made from paper and board and the working group on printed food contact materials. The technical guides published by

1020-442: Is tasked with responding to emerging risks for health arising from the use of cosmetics. By promoting the principles laid down in Council of Europe Resolution ResAP(2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, the committee also works to ensure the safety of these products. Activities on the work programme focus on fostering collaboration between member states and observers. The CD-P-COS oversees

1071-546: The European Commission , WHO , the USFDA and the Council of Europe's Committee on Bioethics (DH-BIO). These experts work together on the ethical, legal and organisational aspects of blood transfusion with a view to ensuring quality, increasing availability, avoiding wastage, ensuring optimal use of blood supplies and analysing the possible ethical and organisational impact of new scientific developments. One outcome of this work,

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1122-724: The European Commission , WHO , the DH-BIO, Eurotransplant , Scandiatransplant, the European Society for Organ Transplantation (ESOT), The Transplantation Society (TTS), the European Association of Tissue and Cells Banks (EATCB), the European Eye Bank Association (EEBA), the European Society of Human Reproduction and Embryology (ESHRE) and the World Marrow Donor Association (WMDA). It actively promotes

1173-707: The European Union (EU) as of March 2020 – are committed to the harmonisation of quality standards for safe medicines throughout the European continent and beyond. In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which

1224-465: The Monographs of the European Pharmacopoeia procedure was initially set up in 1992 as a pilot programme but went on to become routine for chemical substances in 1994; it was expanded in 2003 to include herbal drugs (active substances obtained from plants). Granted after an assessment of the documentation submitted by the applicant, a Certificate of Suitability (CEP) provides proof that the methods used by

1275-454: The Ph. Eur. cover all therapeutic areas and comprise: All the analytical methods described in the monographs are experimentally verified. In addition, the EDQM is responsible for establishing and supplying the official reference standards without which it would be impossible to carry out many of the mandatory quality control tests described in the Ph. Eur. These physical standards are used by manufacturers located both in Europe and around

1326-404: The "Guide to the preparation, use and quality assurance of blood components", provides recommendations on blood collection, blood components, technical procedures, transfusion practices and quality systems for BEs. Through its Blood Proficiency Testing Scheme and Blood Quality Management Programme the committee helps Council of Europe member states improve their blood transfusion services, ensuring

1377-549: The CD-P-MCA are used as reference documents by manufacturers and other business operators, safety evaluators and control laboratories. Partial agreement In 1993 the ground-rules were revised by the Committee of Ministers to take into account new developments. Statutory Resolution (93) 28 of the Committee of Ministers replaced the 1951 resolution. It defines three types of agreement: - A partial agreement: some member States of

1428-425: The Council of Europe (1999) Monographs A monograph is generally a work on one (usually scholarly) subject, or one aspect of a subject, often created by a single author or artist. Traditionally it is in written form and published as a book, but it may be an artwork, audiovisual work, or exhibition made up of visual artworks . In library cataloguing , the word has a specific and broader meaning, while in

1479-399: The Council of Europe; - An enlarged partial agreement: some member States with one or more non-member states; - An enlarged agreement: all member States with one or more non-member states. The Council of Europe currently lists its partial agreements as the following: Partial agreements are traditionally set up with a resolution of the Committee of Ministers. The European Directorate for

1530-606: The EDQM/ Council of Europe in English and French, the two official languages of the Council of Europe, the Ph. Eur. is a compendium of official quality standards for medicines and their ingredients. It thus helps define the requirements to be met by manufacturers seeking to obtain Marketing Authorisation (MA) for a (human or veterinary) medicinal product in Europe, but its standards are also recognised and used worldwide as

1581-552: The European Network of Official Cosmetics Control Laboratories (OCCLs). This network was established in 2010 to maximise the efficiency of cosmetics surveillance by strengthening cross-border collaboration and pooling resources to perform Europe-wide market surveillance studies. Several control laboratories in Asia also take part. In addition to market surveillance studies, network activities include analytical development, PTS studies and

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1632-557: The GMP Guide, and to accept an on site inspection at any time at the request of the EDQM. Source: On 26 May 1994, the European Commission and the Council of Europe decided to launch a new, jointly funded, co-operative venture targeting the quality control of medicines for human and veterinary use on the market, called the European Network of Official Medicines Control Laboratories (OMCLs) . Open to both member states and observers of

1683-702: The International API Inspection Programme (co-ordinated by the European Medicines Agency , or EMA). In addition, the EDQM works closely with World Health Organization (WHO) on the establishment, monitoring and distribution of WHO International Standards for Antibiotics (ISA) and WHO International Chemical Reference Substances (ICRS) which are necessary to apply the tests described in the WHO International Pharmacopoeia . The EDQM therefore plays an essential role in

1734-800: The OCABR procedure guarantees that for the vast majority of the vaccines used in the EU, no batch of vaccine is released to the market in member states without first undergoing an independent quality control by a laboratory of the OMCL Network in addition to the release test conducted by the manufacturer. According to WHO, it is estimated that half of all medicines worldwide are inappropriately prescribed, dispensed or sold, and that half of all patients fail to take their medicines properly. Errors related to medication use, lack of documentation on how medicines are prescribed, used and dispensed, as well as insufficient communication have

1785-407: The Ph. Eur. convention, applying to all medicines on their markets. The contents of the Ph. Eur. are elaborated and updated by the Ph. Eur. Commission, which is responsible for overseeing the practical work of more than 800 experts in every field of the pharmaceutical sciences – all volunteers – who participate in currently 61 groups of experts and working parties. The Ph. Eur. Commission decides on

1836-403: The Ph. Eur. convention, this network is made up of independent public laboratories that have been appointed by their respective national authorities. Their primary mission is to ensure, through random sample testing, that medicines supplied to patients – wherever they are in Europe – comply with the applicable quality standards and the terms and conditions of their MA . The laboratories that form

1887-536: The Quality of Medicines, which is usually listed as a Partial Agreement, falls outside of this definition, being the result of a treaty, and is thus technically a treaty body, such as the European Social Charter organs. There is one agreement, the European Card for Substantially Handicapped Persons, dating from 1977, which was still-born, having never attracted sufficient interest from member states and so

1938-556: The United States, the Food and Drug Administration uses the term to mean a set of published standards. The English term monograph is derived from modern Latin monographia , which has its root in Greek . In the English word, mono- means ' single ' and -graph means ' something written ' . Unlike a textbook , which surveys the state of knowledge in a field, the main purpose of

1989-507: The complex regulatory framework for medicines in Europe. Its primary purpose is to protect public health by enabling the development, supporting the implementation and monitoring the application of quality standards for safe medicines and their safe use. Within the Council of Europe , the EDQM's mission is to contribute to the basic human right of access to good quality medicines and healthcare, and to promote and protect human and animal health by: Directors: Published and regularly updated by

2040-634: The context of Food and Drug Administration regulation, monographs represent published standards by which the use of one or more substances is automatically authorized. For example, the following is an excerpt from the Federal Register : "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products." Such usage has given rise to

2091-428: The data related to the quality of active ingredients used in medicinal products. As previously stated, a CEP is granted after members of the EDQM's panel of assessors (drawn from national medicines agencies throughout Europe) have reviewed a detailed dossier submitted by the manufacturer. This dossier describes the manufacturing process and the tests performed on the raw materials and on the substance produced, as well as

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2142-468: The implementation of harmonised quality management systems. Priority is given to testing products that may present a health risk for consumers, either linked to the presence of prohibited or restricted substances (according to EU legislation) or trace metals. The network also publishes test methods after performing inter-laboratory trials to confirm that these methods are fit for purpose. The European Committee for Food Contact Materials and Articles (CD-P-MCA)

2193-691: The market (market surveillance studies). The EDQM organises inter-laboratory testing activities for OMCLs to improve their analytical performance (proficiency testing scheme [PTS] studies and promotes common quality management systems in all OMCLs to enable work-sharing and mutual recognition of test results. The EDQM also provides the technical secretariat for the Official Control Authority Batch Release (OCABR) procedures for human and veterinary immunological medicinal products (e.g. vaccines) and human blood-derived medicinal products (e.g. clotting factor, immunoglobulin, albumin. For example,

2244-545: The necessary in-process controls. The manufacturer must demonstrate that the article complies with the quality standards laid down in Ph. Eur. and the EU legislation and that the monograph can be used to control impurities , unwanted chemicals that can be present in a substance for a variety of reasons. The applicant must also agree to comply with the relevant EU Good Manufacturing Practice guidelines (GMP guide) as defined in Part II of

2295-406: The network share resources, expertise and workloads: this not only contributes to reducing public health expenditure, a broader coverage of medicines on the market and to the development of future harmonised common standards, but means that laboratories across Europe have access to state-of-the-art technology and selective analytical procedures. Nowadays many laboratories within the network have seen

2346-528: The non-commercialisation of donation, the fight against organ/tissue and cell trafficking and the development of ethical, quality and safety standards in the field of organ, tissue and cell transplantation. An important part of the CD-P-TO's work is the development and publication of two major guides: the "Guide to the quality and safety of organs for transplantation" and the "Guide to the quality and safety of tissues and cells for human application". The EDQM organises

2397-417: The pharmacopoeia remains state-of-the-art. CEPs – which are referred to in EU pharmaceutical legislation – are accepted by the Ph. Eur. member states and by a number of other countries and regions, including Australia , Canada , New Zealand , Saudi Arabia , Singapore , South Africa , Taiwan and Tunisia . An increasing number of licensing authorities worldwide accept CEPs to support (fully or partially)

2448-662: The transfer of knowledge and expertise through training and networking and the monitoring of practices in Europe. They also assess epidemiological risks, in particular those related to the emergence of new infectious agents transmissible by blood transfusion. The work of the Council of Europe in the area of organ, tissue and cell transplantation began in 1987. The guiding principles for the EDQM's activities in this area are ensuring human dignity, maintaining and fulfilling human rights and fundamental freedoms, non-commercialisation of substances of human origin and protecting donors and recipients of organs, tissues and cells. This latter principle

2499-512: The work programme, appoints the experts and adopts the monographs and other texts that comprise the Ph. Eur. (Articles 6 and 7, Ph. Eur. convention. It meets three times a year in Strasbourg (France) and takes all technical decisions by a unanimous vote. The EDQM provides the scientific secretariat and logistical support for the work of the Ph. Eur. Commission, and facilitates the activities of its groups of experts and working parties. The texts of

2550-507: The world, and national and European authorities involved in the quality control of medicines, to name but a few. The EDQM publishes a new edition of the Ph. Eur. every three years. The current chair of the commission is professor Salvador Cañigueral, who was elected in March 2022. Source: The EDQM runs a quality evaluation programme for active ingredients and excipients used in the manufacture of medicines. The Certification of Suitability to

2601-500: Was never implemented. Each agreement has its own form of supervision and management. A number of the agreements are supervised by the Committee of Ministers, others have their own executive boards. In 2007, the activities of the public health partial agreement were transferred to the European Directorate for the Quality of Medicines, despite the fact that the member states were not the same. The agreement on sport heralded

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