Living dossier · 6 linked objects · state as of
Drug regulatory capacity and review priority
When submission volume exceeds review capacity, a regulator has a limited set of moves that do not involve lowering the evidentiary bar: prioritise, cap extensions, allocate reviewers differently, or accept a longer queue. Which move is chosen is a policy decision that is rarely presented as one.
What the law provides
Marketing authorisation and generic approval are statutory functions exercised through regulation and agency guidance. Review prioritisation is ordinarily set by agency policy or guidance rather than by statute, which means it can change without legislation and often without notice-and-comment. Shortage reporting duties, where they exist, are statutory in some jurisdictions and voluntary in others.
The gap
Prioritisation policy determines which medicines reach patients first, and it is made in the instrument with the least public process. A capacity constraint presented as an operational matter is in substance an allocation decision, and the criteria by which one submission is advanced over another are frequently published only in outline.
The KPSGILL position
No position registered. This site has published the mechanics and two Canadian records; it has no data on review-interval outcomes by submission type, and a recommendation on prioritisation criteria without that data would be an opinion wearing a proposal’s clothes.
The open question
Where a regulator prioritises among generic submissions, what is the published criterion, who applies it, and is the resulting interval difference measured? A prioritisation scheme whose effects are not measured cannot be evaluated against the shortage it was meant to relieve.
Litigation
No KPSGILL litigation object yet.
Tracked legislation
No tracked California bill is currently mapped to this topic in the bill registry. A bill tagged to this topic appears here without this dossier being edited.
Everything KPSGILL has published on this
Derived from the topic entity in the entity registry. A page tagged to this topic appears here without this dossier being edited.
How progress would be measured
- Median and tail review intervals by submission type and priority status
- Proportion of submissions receiving priority treatment and on what stated criterion
- Extension frequency and duration against any published cap
- Shortage events with an identified regulatory-interval contribution
- Backlog size over time, published rather than inferred
Entity topic.drug-regulatory-capacity · all dossiers · event timeline · methodology · research program