Our Covid experience showed that rolling submissions can significantly reduce the time it takes to get medication to patients, especially when there’s an urgent public health needLesson 1: One meeting can be worth a thousand e-mails
This significantly cuts down on the usual back and forth, because when the paperwork is eventually submitted, the regulator has had a heads-up about what’s coming and the information the evaluators get to work with is prepared better. This means we’ll have fewer questions for the applicant, and so the review can go quicker.Lesson 2: Eat an elephant one bite at a time — rolling reviews help
Doing rolling reviews also halves the paperwork, because a company submits only one application for registration of their product, instead of putting in a section 21 request first and then later going through another application round.
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