Ankitha R B, Dewan Shailee, Fernandes Francis, Verma Sharad, Bhat Gowri M, Muragundi Pradeep M
Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India.
Deem Eligible Compliance Monitor for UK MHRA, 10, Davy Apartment, 229 Harrow View, Harrow, London Borough of Harrow, HA14GR, UK.
Ther Innov Regul Sci. 2025 May;59(3):438-449. doi: 10.1007/s43441-025-00753-7. Epub 2025 Feb 12.
The United Kingdom (UK)'s regulatory profile is changing following the UK's exit from the European Union (EU). As a consequence, the Medicines and Healthcare products Regulatory Agency (MHRA) became more independent. Since then, numerous attempts have been made to ease the separation of the UK from the European Union, focusing mainly on Northern Ireland (NI), which is part of the UK but shares a land border with the EU. The Windsor Framework facilitates the relationship between the EU and the UK, including the role of the European Medicines Agency (EMA) and MHRA in NI. The review throws light on the implementation of the Windsor Framework detailing the key aspects, and the pre- and post-implementation changes in Northern Ireland, Great Britain and the Republic of Ireland. The Framework is useful for industries such as pharmaceuticals where regulatory approval and an uninterrupted supply chain are critical. Evaluating the Framework illuminate's areas for improvement, threats, and scope for cooperation between the UK and EU authorities. The review details efficiency, costs, and market accessibility of medicines, to give a better representation of the regulatory position in NI. The study reveals the pros and cons of the Framework, to assist stakeholder evaluation of Marketing Authorisation Holders (MAHs) that have registered both in UK and EU markets.
英国脱欧后，其监管格局正在发生变化。因此，药品和医疗产品监管局（MHRA）变得更加独立。自那时以来，人们多次试图缓解英国与欧盟的分离，主要集中在北爱尔兰（NI），北爱尔兰是英国的一部分，但与欧盟有陆地边界。《温莎框架》促进了欧盟与英国之间的关系，包括欧洲药品管理局（EMA）和MHRA在北爱尔兰的作用。该审查揭示了《温莎框架》的实施情况，详细说明了关键方面，以及北爱尔兰、大不列颠及爱尔兰共和国实施前后的变化。该框架对制药等行业很有用，在这些行业中，监管批准和不间断的供应链至关重要。评估该框架有助于明确改进领域、威胁以及英国和欧盟当局之间的合作范围。该审查详细说明了药品的效率、成本和市场可及性，以便更好地反映北爱尔兰的监管状况。该研究揭示了该框架的利弊，以协助利益相关者评估在英国和欧盟市场均已注册的上市许可持有人（MAH）。
