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Regulatory agencies deal in the areas of administrative law, regulatory law, secondary legislation, and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for the benefit of the public at large). The existence of independent regulatory agencies is justified by the complexity of certain regulatory ...
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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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