Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
612-822-4611

  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Impact of Brexit on Submission of Pharmaceutical Products

Impact of Brexit on Submission of Pharmaceutical Products

Pethani, Trupesh
Thumar, Mayuri
Korat, Shruti

Paperback

Medical Reference

ISBN10: 6202438177
ISBN13: 9786202438179
Publisher: LAP Lambert Academic Publishing
Published: Sep 18 2025
Pages: 132
Weight: 0.41
Height: 0.31 Width: 6.00 Depth: 9.00
Language: English
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.

Also from

Pethani, Trupesh

View All

Also in

Medical Reference

View All