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UK MedTech: Pure Global on GSK's Post-Brexit Regulatory Gateway
This week, we unpack the major implications of the UK MHRA's landmark approval of GSK's new twice-yearly asthma treatment. This is more than a product launch; it's a crucial signal for the global MedTech industry on how to successfully navigate the complex and independent post-Brexit regulatory landscape. We explore why the UK is re-emerging as a viable, first-launch market for innovative devices.
We analyze the specific regulatory hurdles that trip up many companies, from UKCA marking to divergent data requirements. We contrast GSK’s success with a case where a European device maker faced an 18-month delay due to a misaligned technical file. This episode is a must-listen for regulatory affairs professionals and business leaders aiming to crack the lucrative UK market.
Key Takeaways:
* What makes the MHRA's approval process fundamentally different from the EU's EMA today?
* How can early engagement with the MHRA through pathways like ILAP accelerate your approval?
* What are the three most common mistakes companies make when submitting EU-centric data to the MHRA?
* Is your current technical file truly prepared for the scrutiny of the UK's standalone requirements?
* Why is appointing the right UK Responsible Person more than just a box-ticking exercise?
* How can you leverage a successful UK launch to streamline approvals in other global markets?
* What are the hidden costs of treating the UK as a secondary market after the EU?
For more insights, contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and medical device database at https://pureglobal.ai/.
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By Ran ChenThis week, we unpack the major implications of the UK MHRA's landmark approval of GSK's new twice-yearly asthma treatment. This is more than a product launch; it's a crucial signal for the global MedTech industry on how to successfully navigate the complex and independent post-Brexit regulatory landscape. We explore why the UK is re-emerging as a viable, first-launch market for innovative devices.
We analyze the specific regulatory hurdles that trip up many companies, from UKCA marking to divergent data requirements. We contrast GSK’s success with a case where a European device maker faced an 18-month delay due to a misaligned technical file. This episode is a must-listen for regulatory affairs professionals and business leaders aiming to crack the lucrative UK market.
Key Takeaways:
* What makes the MHRA's approval process fundamentally different from the EU's EMA today?
* How can early engagement with the MHRA through pathways like ILAP accelerate your approval?
* What are the three most common mistakes companies make when submitting EU-centric data to the MHRA?
* Is your current technical file truly prepared for the scrutiny of the UK's standalone requirements?
* Why is appointing the right UK Responsible Person more than just a box-ticking exercise?
* How can you leverage a successful UK launch to streamline approvals in other global markets?
* What are the hidden costs of treating the UK as a secondary market after the EU?
For more insights, contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and medical device database at https://pureglobal.ai/.