Project:Regulation working group
Working group·shortcut PP:REG
PP:REG.Coordinating regulatory status, importation, access and pricing articles.
The regulation working group covers the legal and economic frame: what regulatory category a substance occupies, how it crosses a border, who pays for it, and what a claim of compliance or certification actually asserts.
Scope
Regulatory status and importation; compounding; good manufacturing practice, ISO certification and drug master files; labelling; insurance, formularies, pricing and access; harm reduction.
What this group will not do
It will not state the law of any jurisdiction. A wiki attempting that will be wrong somewhere and out of date everywhere, and a reader who needs the law of a place needs a source that is maintained for that place. Articles here describe structures — categories, mechanisms, the shape of a claim — and say explicitly that they are not legal advice.
It will also not describe means of avoiding regulatory controls, and it takes no position on what any policy ought to be.
Current priorities
- Reduce the jurisdiction articles to frameworks and move any country-specific material out.
- Ensure every compliance claim article states what particulars would make the claim checkable.
- Keep the access articles descriptive; the neutrality discussion at Talk:Global access disparity is the test case.
- Finish the compounding articles, which are currently the thinnest part of this group's scope.