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Committee On Orphan Medicinal Products
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical 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 n ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 union has a total area of and an estimated population of over 449million as of 2024. The EU is often described as a ''sui generis'' political entity combining characteristics of both a federation and a confederation. Containing 5.5% of the world population in 2023, EU member states generated a nominal gross domestic product (GDP) of around €17.935 trillion in 2024, accounting for approximately one sixth of global economic output. Its cornerstone, the European Union Customs Union, Customs Union, paved the way to establishing European Single Market, an internal single market based on standardised European Union law, legal framework and legislation that applies in all member states in those matters, and only those matters, where the states ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Parliament
The European Parliament (EP) is one of the two legislative bodies of the European Union and one of its seven institutions. Together with the Council of the European Union (known as the Council and informally as the Council of Ministers), it adopts European legislation, following a proposal by the European Commission. The Parliament is composed of 720 members (MEPs), after the June 2024 European elections, from a previous 705 MEPs. It represents the second-largest democratic electorate in the world (after the Parliament of India), with an electorate of around 375 million eligible voters in 2024. Since 1979, the Parliament has been directly elected every five years by the citizens of the European Union through universal suffrage. Voter turnout in parliamentary elections decreased each time after 1979 until 2019, when voter turnout increased by eight percentage points, and rose above 50% for the first time since 1994. The voting age is 18 in all EU member states e ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee For Advanced Therapies
A committee or commission is a body of one or more persons subordinate to a deliberative assembly or other form of organization. A committee may not itself be considered to be a form of assembly or a decision-making body. Usually, an assembly or organization sends matters to a committee as a way to explore them more fully than would be possible if the whole assembly or organization were considering them. Committees may have different functions and their types of work differ depending on the type of organization and its needs. A member of a legislature may be delegated a committee assignment, which gives them the right to serve on a certain committee. Purpose A deliberative assembly or other organization may form a committee (or "commission") consisting of one or more persons to assist with the work of the assembly. For larger organizations, much work is done in committees. They can be a way to formally draw together people of relevant expertise from different parts of an organi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Pharmaceutical Regulation
European, or Europeans, may refer to: In general * ''European'', an adjective referring to something of, from, or related to Europe ** Ethnic groups in Europe ** Demographics of Europe ** European cuisine, the cuisines of Europe and other Western countries * ''European'', an adjective referring to something of, from, or related to the European Union ** European Union citizenship ** Demographics of the European Union In publishing * ''The European'' (1953 magazine), a far-right cultural and political magazine published 1953–1959 * ''The European'' (newspaper), a British weekly newspaper published 1990–1998 * ''The European'' (2009 magazine), a German magazine first published in September 2009 *''The European Magazine'', a magazine published in London 1782–1826 *''The New European'', a British weekly pop-up newspaper first published in July 2016 Other uses * * Europeans (band), a British post-punk group, from Bristol See also * * * Europe (other) * The Europ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee On Herbal Medicinal Products
The Committee on Herbal Medicinal Products (HMPC), is the European Medicines Agency's committee 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 establishment of Community herbal monographs. Composition * 28 members, one nominated by each of the 28 EU Member States The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee On Orphan Medicinal Products
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical 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 n ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee For Medicinal Products For Veterinary Use
The Committee for Veterinary Medicinal Products (CVMP) is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding veterinary medicines. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. See also * Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ... References External links * Health and the European Union Veterinary organizations Pharmacy Animal health Animal husbandry Medicated feed {{eu-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Paediatric-use Marketing Authorisation
Paediatric-use marketing authorisations (PUMA) are granted by the European Medicines Agency (EMA) for medical products that are intended exclusively for paediatric use, that is, for use in patients younger than 18 years. Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children. For this purpose, new data used for PUMA approved drugs are protected for 10 years, and the applications are partially exempt from fees. In September 2011, the first drug was approved under this process. It was Buccolam, a buccal application form of midazolam for the treatment of seizures A seizure is a sudden, brief disruption of brain activity caused by abnormal, excessive, or synchronous neuronal firing. Depending on the regions of the brain involved, seizures ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Committee For Medicinal Products For Human Use
The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal product 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 ...s for human use. See also * Committee for Medicinal Products for Veterinary Use References External links Committee for Medicinal Products for Human Use (CHMP) Health and the European Union {{eu-stub ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vaccine Confidence Project
The Vaccine Confidence Project (VCP) founded in 2010 by Heidi Larson, was developed in response to hesitancy and misinformation on vaccination programmes such as those that caused a boycott of polio eradication efforts in Northern Nigeria in 2003–04. It is an early warning system to identify and evaluate public confidence in vaccines, with the purpose of tackling the problem early, when it is likely to be manageable. Housed in the London School of Hygiene & Tropical Medicine's Vaccine Centre, the VCP uses a diagnostic tool that finds what sparks vaccine rumours, examines and evaluates what spreads those rumours and calculates the potential impact. It is a member of the Vaccine Safety Net, a project led by the World Health Organization. Origins The vaccine confidence project was founded in 2010 by Heidi Larson, and developed in response to rumours and misinformation about vaccines such as those that caused a boycott of polio eradication efforts in Northern Nigeria in 2003� ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Society For Immunotherapy Of Cancer
The Society for Immunotherapy of Cancer (SITC), previously known as the International Society for Biological Therapy of Cancer (iSBTc), is a professional society of scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving outcomes in patients with cancer by advancing the science and application of cancer immunotherapy. Currently, SITC has more than 2,400 members, representing 22 medical specialties from 42 countries around the world, who are engaged in the research and treatment of cancer. Through emphasis on high-caliber scientific meetings, dedication to education and outreach activities, focus on initiatives of major importance to the field, and commitment to collaborations with like-minded organizations and patient advocacy groups, SITC brings together all aspects of the cancer immunology and immunotherapy community in an effort to make cancer immunotherapy one of the four standards of ca ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical guidelines and requirements for pharmaceutical product registration. Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on clinical drug trials that " ove all, the ICH has succeeded in aligning clinical trial requirements." History In the 1980s, the European Union began harmonising regulatory requir ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
