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European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (secommunication on new visual identity an). The EMA was set up in 1995, with funding from the European Union and the pharmaceutical industry, as well as indirect subsidy from member states, its stated intention to harmonise (but not replace) the work of existing national medicine regulatory bodies. The hope was that this plan would not o ...
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European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to ac ...
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Committee On Herbal Medicinal Products
The Committee on Herbal Medicinal Products (HMPC), is the European Medicines Agency's committee A committee or commission is a body of one or more persons subordinate to a deliberative assembly. A committee is not itself considered to be a form of assembly. Usually, the assembly sends matters into a committee as a way to explore them more ... responsible for elaborating the agency's opinions on herbal medicines. Role HMPC aims at assisting in the harmonization of procedures and provisions concerning herbal medicinal products within the European Union, and further integrating herbal medicinal products in the European regulatory framework. HMPC provides EU Member States and European institutions with its scientific opinion on questions relating to herbal medicinal products. Other core tasks include the establishment of a draft 'Community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products', as well as the establishmen ...
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United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the European mainland, continental mainland. It comprises England, Scotland, Wales and Northern Ireland. The United Kingdom includes the island of Great Britain, the north-eastern part of the island of Ireland, and many List of islands of the United Kingdom, smaller islands within the British Isles. Northern Ireland shares Republic of Ireland–United Kingdom border, a land border with the Republic of Ireland; otherwise, the United Kingdom is surrounded by the Atlantic Ocean, the North Sea, the English Channel, the Celtic Sea and the Irish Sea. The total area of the United Kingdom is , with an estimated 2020 population of more than 67 million people. The United Kingdom has evolved from a series of annexations, unions and separations of constituent countries over several hundred years. The Treaty of Union between ...
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Sovereign State
A sovereign state or sovereign country, is a political entity represented by one central government that has supreme legitimate authority over territory. International law defines sovereign states as having a permanent population, defined territory (see territorial disputes), one government, and the capacity to enter into relations with other sovereign states. It is also normally understood that a sovereign state is independent. According to the declarative theory of statehood, a sovereign state can exist without being recognised by other sovereign states.Thomas D. Grant, ''The recognition of states: law and practice in debate and evolution'' (Westport, Connecticut: Praeger, 1999), chapter 1. Unrecognised states will often find it difficult to exercise full treaty-making powers or engage in diplomatic relations with other sovereign states. History Since the end of the 19th century, almost the entire globe has been divided into sections (countries) with more or less define ...
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Orphan Medicine
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to drugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved, due to the economics of drug research and development. In the U.S. and the EU, it is easier to gain marketing approval for an orphan drug. There may be other financial incentives, such as an extended period of exclusivity, during which the producer has sole rights to market the drug. All are intended to encourage development of drugs which would otherwise lack sufficient profit motive to attract corporate research budgets and personnel. Definition According to the US Food and Drug Administration (FDA), an orphan drug is defined as one "intended for ...
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Norway
Norway, officially the Kingdom of Norway, is a Nordic country in Northern Europe, the mainland territory of which comprises the western and northernmost portion of the Scandinavian Peninsula. The remote Arctic island of Jan Mayen and the archipelago of Svalbard also form part of Norway. Bouvet Island, located in the Subantarctic, is a dependency of Norway; it also lays claims to the Antarctic territories of Peter I Island and Queen Maud Land. The capital and largest city in Norway is Oslo. Norway has a total area of and had a population of 5,425,270 in January 2022. The country shares a long eastern border with Sweden at a length of . It is bordered by Finland and Russia to the northeast and the Skagerrak strait to the south, on the other side of which are Denmark and the United Kingdom. Norway has an extensive coastline, facing the North Atlantic Ocean and the Barents Sea. The maritime influence dominates Norway's climate, with mild lowland temperatures on the sea co ...
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Liechtenstein
Liechtenstein (), officially the Principality of Liechtenstein (german: link=no, Fürstentum Liechtenstein), is a German-speaking microstate located in the Alps between Austria and Switzerland. Liechtenstein is a semi-constitutional monarchy headed by the prince of Liechtenstein. Liechtenstein is bordered by Switzerland to the west and south and Austria to the east and north. It is Europe's fourth-smallest country, with an area of just over and a population of 38,749 (). Divided into 11 municipalities, its capital is Vaduz, and its largest municipality is Schaan. It is also the smallest country to border two countries. Liechtenstein is a doubly landlocked country between Switzerland and Austria. Economically, Liechtenstein has one of the highest gross domestic products per person in the world when adjusted for purchasing power parity. The country has a strong financial sector centred in Vaduz. It was once known as a billionaire tax haven, but is no longer on any offici ...
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Iceland
Iceland ( is, Ísland; ) is a Nordic island country in the North Atlantic Ocean and in the Arctic Ocean. Iceland is the most sparsely populated country in Europe. Iceland's capital and largest city is Reykjavík, which (along with its surrounding areas) is home to over 65% of the population. Iceland is the biggest part of the Mid-Atlantic Ridge that rises above sea level, and its central volcanic plateau is erupting almost constantly. The interior consists of a plateau characterised by sand and lava fields, mountains, and glaciers, and many glacial rivers flow to the sea through the lowlands. Iceland is warmed by the Gulf Stream and has a temperate climate, despite a high latitude just outside the Arctic Circle. Its high latitude and marine influence keep summers chilly, and most of its islands have a polar climate. According to the ancient manuscript , the settlement of Iceland began in 874 AD when the Norwegian chieftain Ingólfr Arnarson became the first p ...
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European Union
The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been described as a ''sui generis'' political entity (without precedent or comparison) combining the characteristics of both a federation and a confederation. Containing 5.8per cent of the world population in 2020, the EU generated a nominal gross domestic product (GDP) of around trillion in 2021, constituting approximately 18per cent of global nominal GDP. Additionally, all EU states but Bulgaria have a very high Human Development Index according to the United Nations Development Programme. Its cornerstone, the Customs Union, paved the way to establishing an internal single market based on standardised legal framework and legislation that applies in all member states in those matters, and only those matters, where the states have agreed to ac ...
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Pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025) Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: (Greek for drug) and (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse ev ...
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Tissue Engineering
Tissue engineering is a biomedical engineering discipline that uses a combination of cells, engineering, materials methods, and suitable biochemical and physicochemical factors to restore, maintain, improve, or replace different types of biological tissues. Tissue engineering often involves the use of cells placed on tissue scaffolds in the formation of new viable tissue for a medical purpose but is not limited to applications involving cells and tissue scaffolds. While it was once categorized as a sub-field of biomaterials, having grown in scope and importance it can be considered as a field of its own. While most definitions of tissue engineering cover a broad range of applications, in practice the term is closely associated with applications that repair or replace portions of or whole tissues (i.e. bone, cartilage, blood vessels, bladder, skin, muscle etc.). Often, the tissues involved require certain mechanical and structural properties for proper functioning. The term has a ...
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Somatic Cell
A somatic cell (from Ancient Greek σῶμα ''sôma'', meaning "body"), or vegetal cell, is any biological cell forming the body of a multicellular organism other than a gamete, germ cell, gametocyte or undifferentiated stem cell. Such cells compose the body of an organism and divide through the process of binary fission and mitotic division. In contrast, gametes are cells that fuse during sexual reproduction, germ cells are cells that give rise to gametes, and stem cells are cells that can divide through mitosis and differentiate into diverse specialized cell types. For example, in mammals, somatic cells make up all the internal organs, skin, bones, blood and connective tissue, while mammalian germ cells give rise to spermatozoa and ova which fuse during fertilization to produce a cell called a zygote, which divides and differentiates into the cells of an embryo. There are approximately 220 types of somatic cell in the human body. Theoretically, these cells are not germ cel ...
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