Regulatory Authority

Preferred Label : Regulatory Authority;

NCIt related terms : RegulatoryAuthority; regulatory authorities; health authority;

NCIt definition : A geopolitical organization responsible for regulating products used in health care.;

Alternative definition : CDISC-GLOSS: Bodies having the power to regulate. NOTE: In the ICH GCP guideline the term includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities. [ICH]; BRIDG 3.0.3: 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; BRIDG 5.3: 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 OTHER NAME(S): NOTE(S):;

Details

Origin ID

C88081;

UMLS CUI

C2981655;

Automatic exact mappings (from CISMeF team)
- Health Authority (qualifier value) [Inactive SNOMED CT concept]
Semantic type(s)
- Governmental or Regulatory Activity [UMLS semantic type]
concept_is_in_subset
- BRIDG Class Terminology [NCIt concept]
- BRIDG Terminology [NCIt concept]
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
- FDA Individual Case Safety Report Terminology [NCIt concept]
- Observation ICSR Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

recommendations
documents concerning education
documents for patients