New International: Experiences with the Latest UK Submission Routes

Description: With the advent of Brexit and the subsequent implementation of the Windsor Framework, the MHRA is now the soveriegn regulator for the UK. As a consequence of this, opportunities to adapt the regulatory framework have enabled increased global collaboration with other regulatory agencies, together with the establishment of alternative registration pathways. These offer the opportunity to improve process efficiency whilst maintaining appropriate rigour and standards of assessment, ensuring that the UK remains an attractive location for development and registration of meidicnal products. This session will outline the new submission routes available and give an overview of typical metrics for submission/review/approval timelines.

Identify the new submission routes available for applications submitted to MHRA in the pre- and post-approval setting, together with an awareness of typical metrics for submisison/review/approval timelines.

Appreciate the relative advantages and disadvantages of each submission route and incoporate these points into an overall regulatory strategy.