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The List is associated with the Wikipedia page Guidances for statistics in regulatory affairs that aims to address the various topics of the listed guidances. Regulatory guidances (draft and/or final ) are subject to revisions. Therefore, users of the guidances are advised to consult the original website to check for the latest version.
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 ...
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a ...
The International Organization for Standardization (ISO) and its ISO 37301:2021 (which deprecates ISO 19600:2014) standard is one of the primary international standards for how businesses handle regulatory compliance, providing a reminder of how compliance and risk should operate together, as "colleagues" sharing a common framework with some nuances to account for their differences.
Deposit insurance and resolution authority are also parts of the banking regulatory and supervisory framework. Bank (prudential) supervision is a form of "microprudential" policy to the extent it applies to individual credit institutions, as opposed to macroprudential regulation whose intent is to consider the financial system as a whole.
Policy proposals must also quantify the regulatory burden on individuals, businesses, and community organisations under the viable options. Following announcement of a decision, the impact analysis used to support Government decision-making is published online, as is OIA's assessment of the quality of that analysis and the processes undertaken ...
Executive Order 12866 in the United States, issued by President Clinton in 1993, requires a cost–benefit analysis for any new regulation that is "economically significant", which is defined as having "an annual effect on the economy of $100 million or more or adversely affect[ing] in a material way the economy, a sector of the economy, productivity, competition, [or] jobs," or creating an ...
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.