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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 ...
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.
Pages in category "National agencies for drug regulation" The following 46 pages are in this category, out of 46 total. This list may not reflect recent changes .
Exterior of the Pfizer World headquarters building. Pfizer produced the first COVID-19 vaccine to gain emergency use authorization. Sam Aronov/Pacific Press/LightRocket via Getty ImagesThe Food ...
Eurasia Group Director of Global Strategic Analysis Caitlin Dean discusses the reasons why the U.S. depends on foreign healthcare supplies.
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 Health Committee, [44] for having undergone regulatory capture, i.e. advancing the interests of the drug companies rather than the interests of the public.
The company uses its proprietary Peptide Drug Candidate platform (PDC) to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well ...
Organisations grouping almost all the countries in their respective continents. Note that Cuba is a suspended member of the Organization of American States (OAS). Several smaller regional organizations with non-overlapping memberships. Several non-overlapping large alliances. Softer colors indicate observer/associate or candidate countries.