Whitepaper: European Biotech Act – Regulatory impact and implications for sponsors
This whitepaper provides a clear and concise overview of the Act’s background, intent, and the key pieces of regulatory legislation it is set to influence. It looks into critical areas such as clinical trials and Supplementary Protection Certificate (SPC) extensions, highlighting the improvements expected to accelerate biotech innovation and streamline development pathways across the EU. […]
Expert comment: EU pharma legislation reform – implications for orphan medicines
On 18 Mar 2026, the EU pharma legislation reform got one step closer to formal adoption, with the approval of the outcome of the related interinstitutional negotiations by the European Parliament’s Committee on Public Health (SANT). In this article, we focus on the impact of this EU pharma legislation reform with regards to orphan medicinal […]