Difference between revisions of "Regulatory Authority (RPS)"
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For example, the [[Medicines and Healthcare Products Regulatory Agency]] (MHRA) in UK, the [[Food and Drug Administration]] (FDA) in the USA. | For example, the [[Medicines and Healthcare Products Regulatory Agency]] (MHRA) in UK, the [[Food and Drug Administration]] (FDA) in the USA. | ||
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| + | 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== | ==ICH Equivalent== | ||
Latest revision as of 15:29, 1 October 2008
This is a Glossary page
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
Contents
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.
