英国于2020年12月31日离开欧洲联盟（欧盟）及其附属的欧洲监管机构，包括欧洲药品管理局，从而使药品和医疗保健产品监管局成为一个独立的国家监管机构。这一变化要求对英国药品监管领域进行根本性转变，为肿瘤药物未来的发展创造了机遇与挑战。新的英国药品政策旨在通过提供加快审查途径并与欧洲以外的其他领先国际药品监管机构建立强有力的合作关系，使英国成为一个有吸引力的药物开发和监管审查市场。肿瘤治疗是药物开发和监管审批的关键全球治疗领域，英国政府一直致力于通过批准新的癌症药物来展示监管创新和国际合作。在本政策审查中，我们将调查影响英国肿瘤治疗药物批准的新的英国监管框架、政策和全球合作，探讨英国为下一代癌症药物创建新的独立监管审查和批准流程可能面临的一些挑战。Copyright © 2023 Elsevier Ltd. All rights reserved.

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.Copyright © 2023 Elsevier Ltd. All rights reserved.