UK’s Early Access To Medicines Scheme To Get New Legal Basis
Legal clarity around the core principles of the UK’s early patient access scheme is expected to benefit the pharma industry, patients and healthcare professionals.
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New UK guidance says companies do not have to apply for clinical trial approval or ethics review to collect data on the clinical management of patients receiving unapproved drugs under an early access scheme. However, consent is needed where such data may have research value once collected.
The MHRA’s chief executive explains to the Pink Sheet how the agency will ensure the UK remains an attractive place to seek approval of new innovative drugs and build on the regulatory flexibilities introduced during the COVID-19 pandemic.
The MHRA has drawn up measures to improve regulatory certainty around the UK’s early patient access scheme while reducing regulatory burden in certain areas of its operation.