UK Firms Give First Appraisal Of New Licensing & Access Pathway
Concrete examples of how the UK’s ILAP is working in practice are still thin on the ground, but the general experience of companies so far seems quite positive – albeit with caveats.
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UK Regulator Issues 41 ‘Innovation Passports’ In First Year Of New Pathway
The UK’s ILAP, a post-Brexit scheme introduced in 2021 to accelerate the development of, and access to, new innovative medicines, proved popular in its first year of operation. A total of 71 applications were received last year from companies wanting to take advantage of the regulatory advice, tools and flexibilities on offer.
UK Regulator To Lose 20% Of Staff In Post-Brexit Cost-Cutting Plans
The MHRA intends to drop around 300 roles as it faces a financial crunch after leaving the EU and other pressures.
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.