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The industry's various subdivisions include distinct areas, such as manufacturing biologics, which are all subject to a variety of laws and regulations that govern the patenting, efficacy testing, safety evaluation, and marketing of these drugs. The global pharmaceutical market produced treatments worth a total of $1,228.45 billion in 2020.
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
Setting quality and safety standards in pharmaceutical practices and pharmaceutical care: public authorities and the pharmaceutical industry devote much of their resources to ensuring the quality, safety and efficacy of medicines. However, the best treatment outcomes are only achieved when medicines are used safely and appropriately.
The MHRA is funded by the Department of Health and Social Care for the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry. [6] This has led to suggestions by some MPs that the MHRA is too reliant on industry, and so not fully independent. [7]
The United States Food and Drug Administration (FDA or US FDA) 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 ...
The Regulatory Affairs Journal Pharma (RAJ Pharma) is an English language international pharmaceutical information and analysis service published by Informa plc.First published as a monthly print magazinel in 1992, it includes articles covering worldwide regulatory affairs within the pharmaceutical industry.
Founded in 1958, PhRMA lobbies on behalf of pharmaceutical companies. [ 2 ] [ 3 ] PhRMA is headquartered in Washington, D.C. [ 1 ] The organization has lobbied fiercely against allowing Medicare to negotiate drug prices for Medicare recipients, [ 4 ] and filed lawsuits against the drug price provisions in the Inflation Reduction Act . [ 5 ]