New regulatory routes for cancer treatment in Britain

What do you need to know about post 2020 regulations?

Speed, robust quality, safety and efficacy standards are an important feature in drug development and patient access. The departure of the UK from the EU in 2020 resulted in the Medicines and Healthcare products Regulatory Agency (MHRA) becoming a standalone regulator. This independence provided an opportunity to review the drug development and access pathway. 

The ECMC PO convened a multi-stakeholder working group to bring together in one place the new regulatory approvals processes and the organisations involved.

Working group members

Sarah Blagden

University of Oxford

Paul Catchpole

The Association of the British Pharmaceutical Industry

Nicola Allen-Delingpole

The Association of the British Pharmaceutical Industry

Wendy Fisher

Wendy Fisher Consulting

Alison Hansford

The Association of the British Pharmaceutical Industry

Debbie Keatley

Independent Cancer Patient Voices & National Cancer Research Institute

Daniel O’Connor

Medicines and Healthcare products Regulatory Agency

Matthew Robinson

Accelerated Access Collaborative

Sharan Sandhu

ECMC

Kirsty Wydenbach

Medicines and Healthcare products Regulatory Agency

 

Read the paper here 

The end-to-end process of oncology drug development, approval and access in Great Britain.

Key information from the paper that can also be viewed on the ECMC Website:

 

 

 

“Our writing team wanted to provide a map of the new approvals pathways that could be used by anyone launching a cancer drug in the UK.”
Professor Sarah Blagden