Hofer Matthias P, Criscuolo Paola, Shah Nilay, Ter Wal Anne L J, Barlow James
Imperial College Business School, London, United Kingdom.
Department of Chemical Engineering, Imperial College London, London, United Kingdom.
Front Med (Lausanne). 2022 Dec 15;9:1011082. doi: 10.3389/fmed.2022.1011082. eCollection 2022.
Brexit was presented as an opportunity to promote innovation by breaking free from the European Union regulatory framework. Since the beginning of 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) has operated as the independent regulatory agency for the United Kingdom. The MHRA's regulatory activity in 2021 was analyzed and compared to that of other international regulatory bodies. The MHRA remained reliant on EU regulatory decision-making for novel medicines and there were significant regulatory delays for a small number of novel medicines in the UK, the reasons being so far unclear. In addition, the MHRA introduced innovation initiatives, which show early promise for quicker authorization of innovative medicines for cancer and other areas of unmet need. Longer-term observation and analysis is needed to show the full impact of post-Brexit pharmaceutical regulatory policy.
脱欧被视为摆脱欧盟监管框架以促进创新的契机。自2021年初起，药品和医疗产品监管局（MHRA）已作为英国的独立监管机构开展运作。对MHRA 2021年的监管活动进行了分析，并与其他国际监管机构的活动进行了比较。MHRA在新型药品方面仍依赖欧盟的监管决策，英国少数新型药品出现了重大监管延迟，原因尚不明朗。此外，MHRA推出了创新举措，这些举措在更快批准用于癌症及其他未满足需求领域的创新药物方面显示出了初步前景。需要进行长期观察和分析，以展现脱欧后药品监管政策的全面影响。
