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Regulatory compliance in the European Union (EU) is governed by a harmonized legal framework designed to ensure consistency across member states while allowing for national implementation. EU compliance regulations cover various industries, including consumer product safety, financial services, environmental protection, and data privacy.
Regulatory translation is the translation of documentation pertaining to the approval and compliance of medical devices, pharmaceuticals and in vitro diagnostics products. Many countries around the world, including Japan and the United States, require that approval dossiers for new products be submitted in local languages for the regulatory bodies to read and analyze.
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 ...
Compliance refers to adhering with the mandated boundaries (laws and regulations) and voluntary boundaries (company's policies, procedures, etc.). [ 9 ] [ 10 ] GRC is a discipline that aims to synchronize information and activity across governance, and compliance in order to operate more efficiently, enable effective information sharing, more ...
Legal compliance is the process or procedure to ensure that an organization follows relevant laws, regulations and business rules. [5] The definition of legal compliance, especially in the context of corporate legal departments, has recently been expanded to include understanding and adhering to ethical codes within entire professions, as well.
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.
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.
Regulation in the social, political, psychological, and economic domains can take many forms: legal restrictions promulgated by a government authority, contractual obligations (for example, contracts between insurers and their insureds [1]), self-regulation in psychology, social regulation (e.g. norms), co-regulation, third-party regulation, certification, accreditation or market regulation.