§ Paul FlynnTo ask the Secretary of State for Health what assessment he has made of the average(a) amount and (b) proportion of working days spent on scrutiny of new drug applications that is accounted for by examination of raw data from Phase 3 clinical trials. [179575]
§ Ms Rosie WintertonCompanies are required to submit, for review and assessment, summaries of all the clinical data and these are much more useful than the examination of the actual raw data for helping to determine the quality, safety and efficacy of products. The average amount of time spent by all assessors assessing a new drug is approximately 50 working days, only a small proportion of which is spent on review of raw data.