Regulatory Authority

Definition 1

A geopolitical organization responsible for regulating products used in health care. (NCI Thesaurus)

Definition 2

Governmental bodies that have the power to pass and enforce laws. EXAMPLE(S): Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; Food and Drug Administration (FDA) in the USA (NCI Thesaurus/BRIDG)

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Regulatory Assessment Type Code

A coded value specifying the approval process used by the regulatory authority. EXAMPLE(S): FDA's Center for Devices and Radiological Health (CDRH) Process,FDA's…

Regulatory Assessment Reason Code

A coded value specifying the rationale for a regulatory designation.

Regulatory Assessment Identifier

A unique symbol that establishes identity of the regulatory assessment.

Regulatory Assessment Date

The date (and time) on which this particular assessment is completed.

Regulatory Assessment Code

A coded value specifying the regulatory designation made by the regulatory authority.

Regulatory Assessment

A regulatory action or inaction undertaken by the regulatory authority as a result of a submission analysis and evaluation.