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A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous jurisdiction over some area of human activity in a licensing and regulating capacity.
Independent agencies exist outside the federal executive departments (those headed by a Cabinet secretary) and the Executive Office of the President. [1]: 6 There is a further distinction between independent executive agencies and independent regulatory agencies, which have been assigned rulemaking responsibilities or authorities by Congress.
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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 ...
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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 ...
The federal government maintains a “regulatory agenda” of all regulations under development by executive branch agencies. [1] The requirement to list rules likely to have a significant economic impact on a substantial number of small entities arises under statute, [1] and the requirement to list all other rules arises under Executive Order 12866 § 4(b).