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Mutual Recognition Procedure
The Heads of Medicines Agencies (HMA) is a network of both the human and veterinary medicines agencies of the European Economic Area. The HMA co-operates with the European Medicines Agency and the European Commission (Directorate-General for Health and Food Safety) in the operation of the European medicines regulatory system. The network provides a forum for the co-ordination and the exchange of views and proposals on issues concerning the European regulatory system and the role of the national authorities within that system. The HMA, initially known as the Heads of Agencies, was established in 1995 with a first full meeting taking place in Amsterdam in February 1996. Initially the network comprised only agencies responsible for the regulation of medicines for human use. In February 1998, a parallel group bringing together the heads of agencies responsible for medicines for veterinary use held its first meeting. The two groups started organising joint meetings in 2000 and since ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Governmental Organization
A government or state agency, sometimes an appointed commission, is a permanent or semi-permanent organization in the machinery of government that is responsible for the oversight and administration of specific functions, such as an administration. There is a notable variety of agency types. Although usage differs, a government agency is normally distinct both from a department or ministry, and other types of public body established by government. The functions of an agency are normally executive in character since different types of organizations (''such as commissions'') are most often constituted in an advisory role—this distinction is often blurred in practice however, it is not allowed. A government agency may be established by either a national government or a state government within a federal system. Agencies can be established by legislation or by executive powers. The autonomy, independence, and accountability of government agencies also vary widely. History Early exa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Pharmaceutical Drugs
A medication (also called medicament, medicine, pharmaceutical drug, 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 medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management. Drugs are classified in multiple ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically (such as IVIG), gene therapy, monoclonal antibodies and cell therapy (for instance, stem cell therapies). Other ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Association. The EEA links the EU member states and three EFTA states (Iceland, Liechtenstein, and Norway) into an internal market governed by the same basic rules. These rules aim to enable free movement of persons, goods, services, and capital within the European single market, including the freedom to choose residence in any country within this area. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and Iceland, Liechtenstein, and Norway. The EEA Treaty is a commercial treaty and differs from the EU Treaties in certain key respects. According to Article 1 its purpose is to "promote a continuous and balanced strengthening of trade and economic relati ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 onl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body of about 32,000 European civil servants. The Commission is divided into departments known as Directorates-General (DGs) that can be likened to departments or ministries each headed by a Director-General who is responsible to a Commissioner. There is one member per member state, but members are bound by their oath of office to represent the general interest of the EU as a whole rather than their home state. The Commission President (currently Ursula von der Leyen) is proposed by the European Council (the 27 heads of state/governments) and elected by the European Parliament. The Council of the European Union then nominates the other members of the Commission in agreement with the nominated President, and the 27 members as a team are then ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Directorate-General For Health And Food Safety
The Directorate-General for Health and Food Safety (DG SANTE), until 2014 known as the Directorate-General for Health and Consumers (DG SANCO), is a directorate-general of the European Commission. The DG is responsible for the implementation of European Union laws on food safety and health. It is headed by European Commissioner for Health and Food Safety Stella Kyriakides and Director-General Sandra Gallina. Structure Directorates The directorate-general is made up of seven directorates (as of December 2021): * Directorate A: Resource management and better regulation * Directorate B: Health systems, medical products and innovation * Directorate C: Public Health * Directorate D: Food sustainability, international relations * Directorate E: Food and feed safety, innovation * Directorate F: Health and food audits and analysis * Directorate G: Crisis preparedness in food, animals and plants Directorates A, B, D, E and G are based in Brussels, Directorate C is based in Luxembourg City, ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
1995 Establishments In The European Union
File:1995 Events Collage V2.png, From left, clockwise: O.J. Simpson is acquitted of the murders of Nicole Brown Simpson and Ronald Goldman from the year prior in "The Trial of the Century" in the United States; The Great Hanshin earthquake strikes Kobe, Japan, killing 5,000-6,000 people; The Unabomber Manifesto is published in several U.S. newspapers; Gravestones mark the victims of the Srebrenica massacre near the end of the Bosnian War; Windows 95 is launched by Microsoft for PC; The first exoplanet, 51 Pegasi b, is discovered; Space Shuttle Atlantis docks with the Space station Mir in a display of U.S.-Russian cooperation; The Alfred P. Murrah Federal Building in Oklahoma City is bombed by domestic terrorists, killing 168., 300x300px, thumb rect 0 0 200 200 O. J. Simpson murder case rect 200 0 400 200 Kobe earthquake rect 400 0 600 200 Unabomber Manifesto rect 0 200 300 400 Oklahoma City bombing rect 300 200 600 400 Srebrenica massacre rect 0 400 200 600 Space Shuttle Atlanti ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Agencies Of The European Union
The agencies of the European Union (formally: ''Agencies, decentralised independent bodies, corporate bodies and joint undertakings of the European Union and the Euratom'') are bodies of the European Union and the Euratom established as juridical persons through secondary EU legislation and tasked with a specific narrow field of work. They are distinct from: * international law juridical persons established through primary (treaty) legislation, either as an EU institution (the European Central Bank) or an EU body of other type (such as the European Investment Bank Group entities, the European University Institute, the European Stability Mechanism or the Unified Patent Court) * other EU institutions * other EU bodies lacking juridical personality, including the advisory bodies, the independent offices held by a single person (European Ombudsman, European Data Protection Supervisor), and the (non-independent, auxiliary) EU inter-institutional services, regardless whether establis ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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