All Biotech articles
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Industry newsNew MHRA framework sets out IMA pathway for rare disease therapies
21 May saw the MHRA unveil their draft rare disease framework, which is open for consultation until 30 of July. The new framework aims to adapt the regulatory framework for rare diseases, defined as affecting 1 in 50,000 or less people in the UK, as the current development ...
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JournalImplementation of Regulation (EU) No 536/2014 – A CRO perspective
Significant changes have been implemented to the clinical trials application process with Regulation (EU) No 536/2014 (European Union Clinical Trials Regulation; EU CTR) taking effect on 31 January 2022. This article summarises experience gathered under the new regulatory framework from a contract research organisation (CRO) perspective working ...