 |
The Canadian Agency for Drugs and Technologies in Health, or CADTH, is a Canadian national organisation that provides research and analysis to healthcare decision-makers. [1]
The organisation was established in 1989 by the country's federal government, and those of its provinces and territories. [2] Before April 2006, CADTH was known as the Canadian Coordinating Office for Health Technology Assessment (CCOHTA). [3] [4]
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).
Health Canada is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of healthcare, agricultural, and pharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and pharmaceutical products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.
An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions. An orphan drug would not be profitable to produce without government assistance, due to the small population of patients affected by the conditions. The conditions that orphan drugs are used to treat 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 that depends on the legislation of the country.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
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).
The Centre for Reviews and Dissemination (CRD) is a health services research centre based at the University of York, England. CRD was established in January 1994, and aims to provide research-based information for evidence-based medicine. CRD carries out systematic reviews and meta-analyses of healthcare interventions, and disseminates the results of research to decision-makers in the NHS.
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency responsible for applying medical, pharmaceutical, and scientific expertise to protect and advance public health and safety.
A formulary is a list of pharmaceutical drugs, often decided upon by a group of people, for various reasons such as insurance coverage or use at a medical facility. Traditionally, a formulary contained a collection of formulas for the compounding and testing of medication. Today, the main function of a prescription formulary is to specify particular medications that are approved to be prescribed at a particular hospital, in a particular health system, or under a particular health insurance policy. The development of prescription formularies is based on evaluations of efficacy, safety, and cost-effectiveness of drugs.
Health technology assessment (HTA) is a multidisciplinary process that uses systematic and explicit methods to evaluate the properties and effects of a health technology. Health technology is conceived as any intervention at any point in its lifecycle. HTA aim is to inform "decision-making in order to promote an equitable, efficient, and high-quality health system". It has other definitions including "a method of evidence synthesis that considers evidence regarding clinical effectiveness, safety, cost-effectiveness and, when broadly applied, includes social, ethical, and legal aspects of the use of health technologies. The precise balance of these inputs depends on the purpose of each individual HTA. A major use of HTAs is in informing reimbursement and coverage decisions by insurers and national health systems, in which case HTAs should include benefit-harm assessment and economic evaluation." And "a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Its aim is to inform the formulation of safe, effective, health policies that are patient focused and seek to achieve best value. Despite its policy goals, HTA must always be firmly rooted in research and the scientific method".
Patient participation is a trend that arose in answer to medical paternalism. Informed consent is a process where patients make decisions informed by the advice of medical professionals.
European Network for Health Technology Assessment (EUnetHTA) is a network, established to create an effective and sustainable structure for health technology assessment (HTA) across Europe that could develop and implement practical tools to provide reliable, timely, transparent and transferable information to contribute to HTAs in Member States.
The Institute for Quality and Efficiency in Healthcare (IQWiG) is a German agency responsible for assessing the quality and efficiency of medical treatments, including drugs, non-drug interventions, diagnostic and screening methods, and treatment and disease management. IQWiG also supplies health information to patients and the general public.
The Health Intervention and Technology Assessment Program (HITAP) is a semi-autonomous research unit under Thailand’s Ministry of Public Health. It was established in 2007 as a non-profit organization in order to take responsibility for appraising a wide range of health technologies and programs, including pharmaceuticals, medical devices, interventions, individual and community health promotion, and disease prevention as well as social health policy to inform policy decisions in Thailand. HITAP assumes an advisory role to health governmental authorities by providing rigorous scientific evidence through professional assessment of health data in support of public decision-making. These assessments cover a range of topics including system design, selection of technologies for assessment, and the actual assessment of those selected and agreed upon by relevant government agencies. In this effort, HITAP publishes research and studies in the following areas: methodological development, databases and guidelines; knowledge transfer and exchange (KTE) and capacity development; technology assessments on drugs, medical devices, medical procedures, disease prevention and health promotion measures; benefit packages of care – mixing screening and treatments; and other public health policies, e.g. evaluation of Thailand’s government compulsory license policy.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
Drug recycling, also referred to as medication redispensing or medication re-use, is the idea that health care organizations or patients with unused drugs can transfer them in a safe and appropriate way to another patient in need. The purpose of such a program is reducing medication waste, thereby saving healthcare costs, enlarging medications’ availability and alleviating the environmental burden of medication.
The Swedish Agency for Health Technology Assessment and Assessment of Social Services previously the Swedish Council on Health Technology Assessment is an independent Swedish governmental agency tasked with assessing and evaluating methods in use in healthcare and social services. SBU is tasked with summarizing and communicating evidence and is a knowledge center for both healthcare and social services in Sweden. The agency performs review by systematically searching the literature, evaluating, assuring quality, and weighing together results. SBU does not carry out any original research beyond meta-analysis, systematic review or health technology assessment (HTA). It is one of the world's oldest HTA agencies that started conducting systematic reviews in 1987.
Doravirine/lamivudine/tenofovir, sold under the brand name Delstrigo, is a fixed-dose combination antiretroviral medication for the treatment of HIV/AIDS. It contains doravirine, lamivudine, and tenofovir disoproxil. It is taken by mouth.
BIOTECanada, or the Industrial Biotechnology Association of Canada, is a Canadian biotechnology industry association based in Ottawa, Ontario. It is an industry-funded membership organization composed of over 250 national and international pharmaceutical and gene therapy companies, medical device manufacturers, agricultural science businesses, law firms, academic institutions, research and development networks, advertising agencies, insurance companies and financial services firms.
| International | |
|---|---|
| National | |
 | This article about an organization in Canada is a stub. You can help Wikipedia by expanding it. |
