Table 2.

UK-Windsor Framework vs. EU Regulations.

Comparative analysis	UK Windsor framework	EU pharmaceutical regulations (EMA)
Regulatory Authority	MHRA governs the regulation of medicinal products in UK including Northern Ireland (NI) It operates independently of EMA but maintains cooperation wherever applicable	European Medicines Agency (EMA) oversees regulations of medicinal product across its member states
Marketing Authorisation	All product licenses will be primarily considered to be UK wide All UK application must go through MHRA-specific approval process post Windsor Framework No automatic cross recognition with EMA, separate approval process required for products already authorised in EU	Multiple pathways: Centralised, Decentralised, Mutual recognition and National procedure remains unchanged for market approval across all member states of EU
Pharmacovigilance	Independent Pharmacovigilance system is followed by MHRA Yellow card scheme for reporting adverse event reporting (ADRs)	EudraVigilance database for monitoring and reporting adverse event reporting (ADRs) across EU member states
Pricing and Reimbursement	MHRA determines cost and reimbursement of medicines Separate pricing policies are available for entire UK	Each EU member state determines pricing and reimbursement though EMA encourages transparency and cross border referencing of prices
Labelling	Windsor establishes new labeling (‘UK Only’) requirements in accordance with MHRA	Labelling requirements are established as per EMA directive
Regulatory Compliance	MHRA maintains a uniform compliance in Good Manufacturing Practice (GMP) inspections and safety reporting	EMA coordinates with all member states to ensure organized approach of regulation
Market Access and Trade	Access to any authorised product is uniform throughout UK (including NI) Trade barriers cease to exist within the UK as facilitated in Windsor Framework	Market access in EU single market is independent of authorisation by MHRA Trade barriers will come into existence only between EU and NI