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Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
As of 2016, the EMA was roughly parallel to the drug part of the U.S. Food and Drug Administration (FDA), [53] but without centralisation. [54] The timetable for product approval via the EMA's centralised procedure of 210 days compares well with the average of 500 days taken by the FDA in 2008 to evaluate a product. [55]
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 ...
Since healthcare facilities grant clinical privileges, these organizations will also write to contact other facilities where a provider has worked and obtain professional references to verify experience, competency, and to determine whether any disciplinary actions were taken against the provider. [2] The approval process in a healthcare ...
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.
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Accreditation Association for Ambulatory Health Care (AAAHC) - based in the United States [51] American Accreditation Commission International (AACI) - based in the United States; Community Health Accreditation Program. [52] Det Norske Veritas (DNV) Global Healthcare Accreditation (GHA) [53] Healthcare Facilities Accreditation Program (HFAP) [54]