Advice, guidance and individual details for specific advanced therapy medicinal products

Helen Davis, SPS Horizon Scanning Lead, describes what horizon scanning is, how it is performed for the NHS and it's importance for ATMPs.
Consensus guidance (involving Wave 1 and 2 CAR-T centres) on the management of acute CAR-T cell toxicities.
Practical advice, training and competency assessments for pharmacy departments receiving shipments and storing medicines at ultra-low temperatures.
This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Somatic Cell Therapy Product.
This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Tissue Engineered Products.
This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing Ex-Vivo (cell based) Gene Therapy.
This document outlines key areas for focus of pharmaceutical expertise prior to an organisation implementing In-Vivo (virus based) Gene Therapy.
This document clarifies the regulatory expectation regarding OOS ATMPs and advises hospitals on Governance in the event of an OOS ATMPs being offered for use.
This guidance provides definitions of oversight and supervision it clarifies where each are required when implementing ATMPs.
CAR-T Therapy requires some medicines to be restricted, this guidance provides details and recommended wash-out periods for restricted medicines.

Individual ATMPs

SGT-001

5 April 2021dm+d: Unassigned

Bidridistrogene xeboparvovec

2 April 2021dm+d: Unassigned

RP-L102

2 April 2021dm+d: Unassigned

RP-L201

2 April 2021dm+d: Unassigned

AVR RD 01

11 February 2021dm+d: Unassigned

Olenasufligene relduparvovec

29 January 2021dm+d: Unassigned

MDR-101

29 January 2021dm+d: Unassigned

Autologous bone marrow cell therapy

26 January 2021dm+d: Unassigned