Regulatory Authority (RPS)

From HL7Wiki
Revision as of 15:29, 1 October 2008 by Joelfinkle (talk | contribs) (→‎R1 Working Definition)
(diff) ← Older revision | Latest revision (diff) | Newer revision → (diff)
Jump to navigation Jump to search

This is a Glossary page

This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized

R1 Working Definition

Governmental bodies that have the power to pass and enforce laws.

Specifically for this context, these bodies have the power to approve regulated products.

For example, the Medicines and Healthcare Products Regulatory Agency (MHRA) in UK, the Food and Drug Administration (FDA) in the USA.

For RPS, the Regulatory Authority is typically the recipient of Application (RPS) RPS messages from the Sponsor (RPS), although RPS messages may be sent the other direction, or between sponsors, or contract agencies to sponsors, or between authorities.

ICH Equivalent

None

BRIDG Term

RegulatoryAuthority

Governmental bodies that have the power to pass and enforce laws.

For example, the Medicines and Healthcare Products Regulatory Agency (MHRA) in UK, the Food and Drug Administration (FDA) in the USA.

Additional Regional Definitions and Synonyms