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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/

Do You Know the Requirements for Medical Devices Post Brexit?

The United Kingdom (UK) officially left the European Union (EU) on 31 January 2020. According to the withdrawal agreement, it is now officially a third country to the EU and no longer participates in EU decision making. The agreement established a transition period that ended on 31 December 2020.1 As a result, the Medicines and … Continued

https://www.certara.com/blog/do-you-know-the-requirements-for-medical-devices-post-brexit/

Are you ready for 2021? – Remember Brexit in Your Pediatric Planning

By Eva Berglund When writing this, it’s just before Christmas and 14 days are left in 2020. As we all know, Brexit—the withdrawal of the United Kingdom from the European Union— is coming up and thereby new rules for pediatric drug developers come into place for the UK in 2021. Transitional rules The EU uses … Continued

https://www.certara.com/blog/are-you-ready-for-2021-remember-brexit-in-your-pediatric-planning/

Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no … Continued

https://www.certara.com/blog/brexit-impact-on-eudract/

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/

Major Medical Device Regulatory Changes Taking Shape in 3 Key Geographies

Medical device manufacturers are constantly navigating the regulatory world. And like most other industries in 2022 and beyond, that world looks to be more complex and dynamic than ever. Particularly in the EU, UK, and US, change is unfolding at an unprecedented pace and with greater stakes as governing bodies envision and adjust to the … Continued

https://www.certara.com/blog/medical-device-regulatory-changes-geographics/

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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