Abstract
The departure of the UK from the European Union (EU) and affiliated European regulatory bodies, including the European Medicines Agency, on Dec 31, 2020, has resulted in the Medicines and Healthcare products Regulatory Agency becoming an independent national regulator. This change has required a fundamental transformation of the UK drug regulatory landscape, creating both opportunities and challenges for future development of oncology drugs. New UK pharmaceutical policies have sought to make the UK an attractive market for drug development and regulatory review, by offering expedited review pathways coupled to strong collaborative relations with other leading international medicines regulators, outside of Europe. Oncology is a key global therapy area for both drug development and regulatory approval, and the UK Government has been keen to show regulatory innovation and international collaboration through approval of new cancer medicines. In this Policy Review, we examine the new UK regulatory frameworks, policies, and global collaborations affecting new oncology drug approvals after departure from the EU. We explore some of the challenges that might lie ahead as the UK creates new and independent regulatory review and approval processes for the next generation of cancer medicines.
Original language | English |
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Pages (from-to) | e150-e160 |
Number of pages | 11 |
Journal | The Lancet Oncology |
Volume | 24 |
Issue number | 4 |
Early online date | 27 Mar 2023 |
DOIs | |
Publication status | Published - Apr 2023 |
Bibliographical note
AcknowledgmentsWe thank Aaron Kesselheim for his invaluable critical feedback in the evaluation of this manuscript. MPL would also like to thank the British National Formulary Committee, Joint Formulary Committee and the MHRA Project Orbis for providing clarification in some of the data acquisition.