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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Glossary category

Regulatory

Terms describing the status of a compound before a competent authority.

Terms

9 documents

Table 1. Terms in the regulatory category.

TermDefinition
ATC codeThe Anatomical Therapeutic Chemical classification assigned by the World Health Organization. Assigned to authorised substances; its absence indicates that no authorisation has been granted.
Boxed warningBlack box warningThe most prominent warning a competent authority can require in product information. Signals regulatory concern; does not itself establish that the risk is realised in humans.
CAS numberCAS registry numberA unique identifier assigned to a chemical substance by the Chemical Abstracts Service. An identifier and not a statement of legal or quality status.
Compounded preparationA preparation made by a pharmacy for an individual patient. Subject to a different regulatory framework from a manufactured medicine, and not equivalent to an authorised product.
Marketing authorisationApprovalPermission from a competent authority to place a medicine on the market for a stated indication. Specific to product, indication, presentation and jurisdiction.
Notoriety biasIncreased reporting of an adverse event following publicity about it, which inflates a pharmacovigilance signal without any change in incidence.
Off-labelUse of an authorised product outside the terms of its authorisation. A regulated product used outside its licence, and distinct from an unapproved product, though the two are frequently conflated.
PharmacovigilanceThe collection and analysis of reports of suspected adverse reactions after authorisation. Establishes that an event has been reported and, for an event named in a warning, is confounded by reporting behaviour.
UnapprovedHolding no marketing authorisation for the use in question. A compound may be approved in one indication and unapproved in another, and approved in one jurisdiction and unapproved in another.
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