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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 ).
In 2005, the MHRA was criticised by the House of Commons Health Committee for, among other things, lacking transparency, [41] and for inadequately checking drug licensing data. [42] The MHRA and the US Food and Drug Administration were criticised in the 2012 book Bad Pharma, [43] and in 2004 by David Healy in evidence to the House of Commons ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Food and Drug Administration (Thai FDA) 2016 Turkey: Turkish Medicines and Medical Devices Agency (TMMDA) 2018 Ukraine: State Service for Medications and Drugs Control (SMDC) 2011 United Kingdom: Medicines and Healthcare products Regulatory Agency (MHRA) Veterinary Medicines Directorate (VMD) 1999 2014 United States: U.S. Food and Drug ...
When two drugs affect each other, it is a drug–drug interaction (DDI). The risk of a DDI increases with the number of drugs used. [1] A large share of elderly people regularly use five or more medications or supplements, with a significant risk of side-effects from drug–drug interactions. [2] Drug interactions can be of three kinds:
FDA accepts Pfizer's (PFE) NDA for ritlecitinib for treating severe alopecia areata. The EMA also accepts the MAA for a similar patient population.
Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants ...
In addition to the member states there are currently 30 observers, including the World Health Organization (WHO) and the Taiwan Food and Drug Administration (TFDA). The EDQM's quality standards for medicines are published in the European Pharmacopoeia (officially abbreviated to Ph. Eur.), which is recognised as a scientific benchmark worldwide ...
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