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A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...
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.
The term regulatory state refers to the expansion in the use of rulemaking, monitoring and enforcement techniques and institutions by the state and to a parallel change in the way its positive or negative functions in society are being carried out. [1] The expansion of the state nowadays is generally via regulation and less via taxing and ...
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 ...
Regulatory policies involve government intervention in the form of laws, regulations, and oversight. Examples include environmental regulations, labor laws, and safety standards for food and drugs. Another example of a fairly successful public regulatory policy is that of a highway speed limit. [4]
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).
Regulatory law refers [1] to secondary legislation, including regulations, promulgated by an executive branch agency under a delegation from a legislature; as well as legal issues related to regulatory compliance. It contrasts with statutory law promulgated by the legislative branch, and common law or case law promulgated by the judicial branch.
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 ...