‘Unbalanced’ EU HTA Timelines Exacerbated By Rare Disease & Cancer Drugs

As it stands, drugmakers will have just 90 days to prepare their dossiers for EU-wide joint clinical assessments under the new Health Technology Assessment Regulation. Market access experts from EFPIA tell the Pink Sheet that this short deadline could delay patient access to complex medicines, such as innovative cancer drugs.

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Last month, the European Commission published a draft implementing act for joint clinical assessments (JCAs), one of the key new processes that will be introduced under the Health Technology Assessment Regulation ((EU) 2021/2282), which is set to apply from January 2025.

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