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 period out of the EU, the MHRA and the UK government made efforts to minimize this impact, with the MHRA now the standalone regulator in the UK.
Research from Imperial College London suggests the UK has fallen behind the EU in its first post-Brexit year when approving novel medicines, with 35 approved in 2021, compared with 40 in the EU and 52 in the US. This webinar will examine in detail the current state of play in medicine in the UK. Hear directly from key opinion leaders as they share insight into the latest regulatory issues.
Learning Objectives
The webinar will take the form of an online discussion examining:
- Next steps for the MHRA.
- New licensing routes, such as the Innovative Licensing and Access Pathway (ILAP) for new chemical entities, biological medicines, new indications, and repurposed medicines, a model to consider for accelerated market access.
- Challenges facing companies getting medicines on the market.
- Hints and tips to navigate the regulatory maze.