EU pharmaceutical legislation revisions: what are the implications for biopharma?
European Pharmaceutical Review
DECEMBER 20, 2023
1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. The second is an adjustment of unmet need categorisation required for RDP extension; unmet need definition now encompasses ‘meaningful’ impact patient outcomes (notably including quality of life).
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