Advanced Therapy Medicinal Products (ATMPs) Roadmap

This Roadmap sets out the key steps and activities in the end-to-end pathway for Advanced Therapy Medicinal Products (ATMPs) in England from non-clinical research through to patient treatment & monitoring.

ABPI is a supportive partner of the Accelerated Access Collaborative (AAC) and has led the AAC’s ATMP Early Stage Product Workstream 3 to develop a roadmap that sets out the key steps and activities in the end-to-end pathway for ATMPs in England from non-clinical research through to patient treatment. The roadmap signposts where differences exist between devolved nation (Scotland, Wales and Northern Ireland) and by ATMP archetype (i.e. cell, gene and tissue-engineered products).

There are a significant number of ATMPs expected to be launched in the coming years and the ATMP Roadmap has been designed to help companies and other ecosystem partners and stakeholders to navigate the ATMP landscape and gain a deeper understanding of:

• Steps and activities that are mandatory or optional at each stage of the ATMP pathway.
• When these steps and activities should be conducted.
• The external guidance available at each stage of the ATMP pathway and where to find it.
• The stakeholders involved at each point through the pathway.
• Best practices/tips to help navigate the pathway.