Pink Sheet, the Citeline regulatory publication, reporter Eliza Slawther has interviewed Mark Mayhew, Treehill Partners, concerning the evolving regulatory landscape in Europe, resulting in two published articles. Mark discusses key industry opportunities and challenges resulting from these far-reaching evolutions.
In the European Union, on 12 January 2025 new Health Technology Assessment (HTA) Regulation began to apply. For new advanced therapy medicinalproducts and oncology treatments filed in the EU, JCAs, which are similar to relative clinical efficacy assessments and were previously conducted by individual member states, will now be carried out at an EU-level.
- Pharmaceutical companies need to “pressure test” their clinical development strategies earlyfor health technology assessment purposes, particularly in light of the new EU HTA Regulation.
- Firms that are “tough on themselves” instead of being overly optimistic when it comes tohealth economic modelling are likely to fare best.
The European Health Data Space (EHDS) Regulation began to enter into force in the EU on 26 March 2025.
- It allows pharma companies and other scientific research entities to request access to large swathes of anonymized or pseudo-anonymized health data from sources such as biobanks, electronic health records or even other companies in EU member states for purposes other than the reason the data was collected in thefirst place.
- Pharma companies could improve their assessment of unmet needs in drug indications, and better understand the correlations between a product’s primary indication and patient comorbidities.
The Clinical Trial Regulations (CTR), which became fully applicable on 31 January 2025 and replaced the former Clinical Trials Directive after a three-year transition period, is designed to harmonize the rules for conductingclinical trials throughout the EU.
Proceed to PinkSheet to read the full articles:
Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA