How we generate our guidance on ATMPs
The Pan-UK Working Group for ATMPs is an expert body supporting UK pharmacies to facilitate ATMP usage. The group is made up of 3 subgroups: Regulatory, Governance and Technical Services; Clinical Trials and Clinical and Education.
Recently published guidance
Our most recently updated or new guidance, listed in date order.
Fundamentals
Key advice on the fundamentals of marketed, investigational and unlicensed ATMPs. Further information can be found below in the Clinical trials section.
Governance
Advice to guide local governance around implementing, managing and recording the use of marketed, investigational and unlicensed ATMPs. Further information can be found below in the Clinical trials section.
- Requirements for governance and preparation of gene therapy
- Exporting ATMP starting materials
- Pharmacy oversight and supervision when preparing cellular ATMPs
- Advice for Chief Pharmacists on ATMP governance requirements
Pharmacy institutional readiness guidance
Pharmacy institutional readiness guidance on governance and operational expectations for marketed, investigational and unlicensed ATMPs. Further information can be found below in the Clinical trials section.
Gene therapy medicinal products
Gene therapy treats, prevents or diagnoses a disease as a result of its recombinant nucleic acid, which regulates, repairs, replaces, adds or deletes a genetic sequence.
- In-vivo GMO gene therapy medicinal products
- Ex-vivo GMO gene therapy medicinal products
- Marketed CAR-T therapy
- In-vivo non-GMO gene therapy medicinal products
- Ex-vivo non-GMO gene therapy medicinal products
- Exagamglogene autotemcel (Casgevy®)
Somatic cell therapy medicinal products
Somatic cell therapy contains cells or tissues that have been manipulated to change their biological characteristics which are intended to cure, diagnose or prevent diseases.
Tissue engineered products
Tissue engineered products contain cells or tissues that have been modified so they can be used to repair, regenerate or replace human tissue.
Operational guidance
Advice and guidance on operational aspects of marketed, investigational and unlicensed ATMP use. Further information can be found below in the Clinical trials section.
- Product design considerations for optimising ATMP implementation
- Performing preparation risk assessments for ATMPs
- Managing out of specification ATMPs
Outsourcing and insourcing
Advice and templates to guide local outsourcing or insourcing by the NHS pharmacy provider.
- Outsourcing marketed ATMPs: A template technical agreement
- Outsourcing ATIMP storage or preparation across legal boundaries
- Undertaking an audit of a cell therapy laboratory
- Outsourcing ATIMP handling: A template technical agreement
Clinical guidance
Clinical guidance to facilitate treatment with ATMPs.
- Supportive medicines guidance for adults on CAR-T cell therapy
- Diagnosing and managing acute CAR-T cell toxicities in adults
- Medication restrictions for CAR-T cell therapy
Clinical trials
Advice and guidance to support the provision of pharmacy clinical trials services for ATMPs.
- Product design considerations for optimising ATMP implementation
- Operating as an NHS clinical trial site post EU Exit
- Outsourcing ATIMP storage or preparation across legal boundaries
- Costing clinical trials of ATIMPs using the NIHR iCT
- Undertaking an audit of a cell therapy laboratory
- Outsourcing ATIMP handling: A template technical agreement
- Pharmacy manual checklist for clinical trials for ATIMPs
Workforce
Additional resources about ATMPs to aid professional development.