Following the UK’s departure from the EU, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator. To launch and / or maintain successful drug development programs in the UK, sponsors need to be aware of the new regulatory requirements and procedures.
From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) introduced changes to licensing procedures, including adding procedures to prioritise access to new medicines.
In this webinar we will provide early initial insights as the industry continues to adapt to the post-transition period.
We will discuss the following:
- Implications of leaving the EU regulatory system
- What are the major changes compared to the EU regulatory system
- Regulatory aspects of new Marketing Authorisations in UK post Brexit
- International collaborative procedures (Access Consortium and Project Orbis)