EU Pilot Shows Single Drug Development Plan Can Meet Both Regulator And HTA Needs
This article was originally published in SRA
The EU's pilot exercise in offering drug developers parallel regulatory and health technology assessment (HTA) advice has shown that in most cases a single trial design or drug development plan can be agreed that meets the requirements of the two parties without blurring their respective remits, says a new report from the European Medicines Agency1.
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The EU research-based pharmaceutical industry has welcomed the launch of a new single gateway for companies to seek parallel scientific advice from the European Medicines Agency and health technology assessment bodies on initial evidence generation and post-authorization data collection. The industry hopes the initiative will help deliver one single evidence package for regulatory and HTA purposes.
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