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RAPS Sponsored Webcast: Navigating the UK Drug Approval Landscape Post-Brexit

The UK Medicines and Healthcare products Regulatory Agency (MHRA) gained independence from the EU regulatory system in 2021, allowing it to make decisions about the approval of medicines in the UK without being influenced by the EU, except for in Northern Ireland, which is covered by the Protocol on Ireland/Northern Ireland. Throughout its the transition … Continued

https://www.certara.com/on-demand-webinar/raps-sponsored-webcast-navigating-the-uk-drug-approval-landscape-post-brexit/

The UK Regulatory Landscape for Drugs Three Years into Brexit

By: Claire Dyer, Director Global Submissions; Justin Hay, Senior Director; Daniel Smith, Director Regulatory Strategy Brexit reached a significant milestone at the end of January 2023 – three years since the United Kingdom left the European Union. Whilst we’ll be debating its relative merits and pitfalls for decades to come, here in the pharmaceutical industry … Continued

https://www.certara.com/article/the-uk-regulatory-landscape-for-drugs-three-years-into-brexit/

A Guide to the UK Regulation of Medicines and Medical Devices Post-Brexit

https://www.certara.com/white-paper/a-guide-to-the-uk-regulation-of-medicines-and-medical-devices-post-brexit/

Recap of EMA’s Policy 0070 Restart Webinar

On 16 May 2023, the European Medicines Agency (EMA) held a webinar to announce plans to restart the publication of clinical data contained in regulatory submissions under Policy 0070. The Policy was originally suspended in 2018 as part of EMA’s Business Continuity Plan for its relocation in the wake of Brexit (read about it in … Continued

https://www.certara.com/blog/recap-of-emas-policy-0070-restart-webinar/

How to expedite patient access to medicines through the Innovative Licensing and Access Pathway (ILAP) in the UK

One word you don’t hear too often in current political discourse relating to Brexit is ‘streamlining’; but that’s exactly what the UK’s regulator hoped its Innovation Passport, which forms part of the Innovation Licensing and Access Pathway, would do for getting new drugs on the market more effectively when it was launched in early 2021.

https://www.certara.com/article/how-to-expedite-patient-access-to-medicines-through-the-innovative-licensing-and-access-pathway-ilap-in-the-uk/

FDA Seeking Feedback on Drug Approval Transparency and Disclosure Efforts

Background In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information … Continued

https://www.certara.com/blog/fda-seeking-feedback-on-drug-approval-transparency-and-disclosure-efforts/

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