Impact of Brexit on Submission of Pharmaceutical Products

ISBN-13: 9786202438179 / Angielski / Miękka / 2025 / 132 str.

Trupesh Pethani; Mayuri Thumar; Shruti Korat

Opis

Brexit has significantly reshaped pharmaceutical product submissions by separating the UK from the EU's centralized regulatory framework. Before Brexit, the European Medicines Agency (EMA) oversaw marketing authorizations, ensuring harmonized access across member states. Now, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) independently regulates medicines, requiring separate applications for UK and EU markets. This has led to duplication of dossiers, increased costs, and potential delays in patient access to innovative medicines. The loss of EU funding, research collaborations, and access to databases like EudraVigilance has also impacted innovation, pharmacovigilance, and clinical trials. New UK systems, including UKCA marking and national submission routes, aim to fill gaps but challenge smaller companies. While Brexit introduces complexity and uncertainty, it also offers the UK opportunities to develop flexible, faster approval pathways and strengthen its position as a research hub, provided collaboration and investment continue.