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List Of Stringent Regulatory Authorities
A stringent regulatory authority (SRA) is a national drug regulation authority which is considered by the World Health Organization (WHO) to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization. The official WHO definition is The concept of an SRA was developed by the WHO Secretariat and The Global Fund to Fight AIDS, Tuberculosis and Malaria The Global Fund to Fight AIDS, Tuberculosis and Malaria (or simply the Global Fund) is an international financing and partnership organization that aims to "attract, leverage and invest additional resources to end the epidemics of HIV/AIDS, ... to guide decisions regarding procurement of medicines for humanitarian assistance. The idea is that countries with non-SRA drug authorities can use accelerated process to facilitate approval (registration or marketing authorization) of medicines, including vaccines and biologics, which have already ...
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Regulation Of Therapeutic Goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia. The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be sold. There is usually some degree of restriction on the availability of certain therapeutic goods, depending on their risk to consumers. History Modern drug regulation has historical roots in the response to the proliferation of universal antidotes which appeared in the wake of Mithridates' death. ...
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Austrian Agency For Health And Food Safety
Austrian may refer to: * Austrians, someone from Austria or of Austrian descent ** Someone who is considered an Austrian citizen, see Austrian nationality law * Austrian German dialect * Something associated with the country Austria, for example: ** Austria-Hungary ** Austrian Airlines (AUA) ** Austrian cuisine ** Austrian Empire ** Austrian monarchy ** Austrian German (language/dialects) ** Austrian literature ** Austrian nationality law ** Austrian Service Abroad ** Music of Austria ** Austrian School of Economics * Economists of the Austrian school of economic thought * The Austrian Attack variation of the Pirc Defence chess opening. See also * * * Austria (other) * Australian (other) Australian(s) may refer to: Australia * Australia, a country * Australians, citizens of the Commonwealth of Australia ** European Australians ** Anglo-Celtic Australians, Australians descended principally from British colonists ** Aboriginal Au ... * L'Autrichienne (d ...
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Estonia
Estonia, formally the Republic of Estonia, is a country by the Baltic Sea in Northern Europe. It is bordered to the north by the Gulf of Finland across from Finland, to the west by the sea across from Sweden, to the south by Latvia, and to the east by Lake Peipus and Russia. The territory of Estonia consists of the mainland, the larger islands of Saaremaa and Hiiumaa, and over 2,200 other islands and islets on the eastern coast of the Baltic Sea, covering a total area of . The capital city Tallinn and Tartu are the two largest urban areas of the country. The Estonian language is the autochthonous and the official language of Estonia; it is the first language of the majority of its population, as well as the world's second most spoken Finnic language. The land of what is now modern Estonia has been inhabited by '' Homo sapiens'' since at least 9,000 BC. The medieval indigenous population of Estonia was one of the last " pagan" civilisations in Europe to adopt Ch ...
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Danish Medicines Agency
The Danish Medicines Agency (Lægemiddelstyrelsen) is an agency under the Danish Ministry of Health and Prevention. The purpose of the agency is to ensure that medicinal products used in Denmark are of satisfactory quality, are safe to use and that they have the desired effect. It supervises companies manufacturing and distributing medicinal products. This is done through administering the Danish legislation on medicinal products, reimbursement, pharmacies, medical devices and euphoriants. The Agency takes part in the Danish innovation system Biopeople at the University of Copenhagen The University of Copenhagen ( da, Københavns Universitet, KU) is a prestigious public research university in Copenhagen, Denmark. Founded in 1479, the University of Copenhagen is the second-oldest university in Scandinavia after Uppsala Unive .... References External linksOfficial website (in English) Medical and health organizations based in Denmark {{denmark-gov-stub ...
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Denmark
) , song = ( en, "King Christian stood by the lofty mast") , song_type = National and royal anthem , image_map = EU-Denmark.svg , map_caption = , subdivision_type = Sovereign state , subdivision_name = Danish Realm, Kingdom of Denmark , established_title = History of Denmark#Middle ages, Consolidation , established_date = 8th century , established_title2 = Christianization , established_date2 = 965 , established_title3 = , established_date3 = 5 June 1849 , established_title4 = Faroese home rule , established_date4 = 24 March 1948 , established_title5 = European Economic Community, EEC 1973 enlargement of the European Communities, accession , established_date5 = 1 January 1973 , established_title6 = Greenlandic home rule , established_date6 = 1 May 1979 , official_languages = Danish language, Danish , languages_type = Regional languages , languages_sub = yes , languages = German language, GermanGerman is recognised as a protected minority language in t ...
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State Institute For Drug Control
The State Institute for Drug Control (Státní ústav pro kontrolu léčiv) is a Czech government agency responsible for regulation of the safe production of pharmaceuticals in the country, clinical evaluation of medicines and for monitoring the advertising and marketing of both medicines and medical devices. Its powers stem from the Act on Public Health Insurance (Act No. 48/1997 Coll.). Only part of its operating costs are directly funded. It is largely self-financing through charges for its services. The SÚKL sets maximum ex-factory prices for reimbursement based on 195 reference groups of therapeutically interchangeable products of similar clinical efficacy. More than 20% of the health budget is spent on medication and medical devices. From January 2019 it took responsibility for regulating the reimbursement of consumer medical devices prescribed as part of outpatient care. It allocates codes and names of medications for use in the electronic prescribing system. It has ...
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Czech Republic
The Czech Republic, or simply Czechia, is a landlocked country in Central Europe. Historically known as Bohemia, it is bordered by Austria to the south, Germany to the west, Poland to the northeast, and Slovakia to the southeast. The Czech Republic has a hilly landscape that covers an area of with a mostly temperate continental and oceanic climate. The capital and largest city is Prague; other major cities and urban areas include Brno, Ostrava, Plzeň and Liberec. The Duchy of Bohemia was founded in the late 9th century under Great Moravia. It was formally recognized as an Imperial State of the Holy Roman Empire in 1002 and became a kingdom in 1198. Following the Battle of Mohács in 1526, the whole Crown of Bohemia was gradually integrated into the Habsburg monarchy. The Protestant Bohemian Revolt led to the Thirty Years' War. After the Battle of White Mountain, the Habsburgs consolidated their rule. With the dissolution of the Holy Empire in 1806, the Cro ...
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Cyprus
Cyprus ; tr, Kıbrıs (), officially the Republic of Cyprus,, , lit: Republic of Cyprus is an island country located south of the Anatolian Peninsula in the eastern Mediterranean Sea. Its continental position is disputed; while it is geographically in Western Asia, its cultural ties and geopolitics are overwhelmingly Southern European. Cyprus is the third-largest and third-most populous island in the Mediterranean. It is located north of Egypt, east of Greece, south of Turkey, and west of Lebanon and Syria. Its capital and largest city is Nicosia. The northeast portion of the island is ''de facto'' governed by the self-declared Turkish Republic of Northern Cyprus, which was established after the 1974 invasion and which is recognised as a country only by Turkey. The earliest known human activity on the island dates to around the 10th millennium BC. Archaeological remains include the well-preserved ruins from the Hellenistic period such as Salamis and Kourion, and Cypr ...
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Agency For Medicinal Products And Medical Devices Of Croatia
Agency may refer to: Organizations * Institution, governmental or others ** Advertising agency or marketing agency, a service business dedicated to creating, planning and handling advertising for its clients ** Employment agency, a business that serves as a representative, acting on behalf of another ** Government agency, a department of a local or national government responsible for the oversight and administration of a specific function *** Central Intelligence Agency, nicknamed "The Agency" ** International agency, an inter-governmental body ** News agency ** Talent agency Social science * Agency, the abstract principle that autonomous beings, agents, are capable of acting by themselves; see Autonomy * Agency (law), a person acting on behalf of another person * Agency (moral), capacity for making moral judgments * Agency (philosophy), the capacity of an autonomous agent to act, relating to action theory in philosophy * Agency (psychology), the ability to recognize or att ...
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Croatia
, image_flag = Flag of Croatia.svg , image_coat = Coat of arms of Croatia.svg , anthem = "Lijepa naša domovino"("Our Beautiful Homeland") , image_map = , map_caption = , capital = Zagreb , coordinates = , largest_city = capital , official_languages = Croatian , languages_type = Writing system , languages = Latin , ethnic_groups = , ethnic_groups_year = 2021 , religion = , religion_year = 2021 , demonym = , government_type = Unitary parliamentary republic , leader_title1 = President , leader_name1 = Zoran Milanović , leader_title2 = Prime Minister , leader_name2 = Andrej Plenković , leader_title3 = Speaker of Parliament , leader_name3 = Gordan Jandroković , legislature = Sabor , sovereignty_type ...
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Canada
Canada is a country in North America. Its ten provinces and three territories extend from the Atlantic Ocean to the Pacific Ocean and northward into the Arctic Ocean, covering over , making it the world's second-largest country by total area. Its southern and western border with the United States, stretching , is the world's longest binational land border. Canada's capital is Ottawa, and its three largest metropolitan areas are Toronto, Montreal, and Vancouver. Indigenous peoples have continuously inhabited what is now Canada for thousands of years. Beginning in the 16th century, British and French expeditions explored and later settled along the Atlantic coast. As a consequence of various armed conflicts, France ceded nearly all of its colonies in North America in 1763. In 1867, with the union of three British North American colonies through Confederation, Canada was formed as a federal dominion of four provinces. This began an accretion of provinces an ...
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Bulgarian Drug Agency
Bulgarian may refer to: * Something of, from, or related to the country of Bulgaria * Bulgarians, a South Slavic ethnic group * Bulgarian language, a Slavic language * Bulgarian alphabet * A citizen of Bulgaria, see Demographics of Bulgaria * Bulgarian culture * Bulgarian cuisine, a representative of the cuisine of Southeastern Europe See also * * List of Bulgarians, include * Bulgarian name, names of Bulgarians * Bulgarian umbrella, an umbrella with a hidden pneumatic mechanism * Bulgar (other) * Bulgarian-Serbian War (other) The term Bulgarian-Serbian War or Serbian-Bulgarian War may refer to: * Bulgarian-Serbian War (839-842) * Bulgarian-Serbian War (853) * Bulgarian-Serbian wars (917-924) * Bulgarian-Serbian War (1330) * Bulgarian-Serbian War (1885) * Bulgarian-Serbi ... {{disambiguation Language and nationality disambiguation pages ...
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