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Key Pathway Resources

Resources by regulatory agencies:

EMA logo

European Medicines Agency

Key European Medicines Agency (EMA) resources for cell and gene therapy development.
MHRA logo

UK MHRA Resources

Key resources for gene and cell therapy developers in the UK context from the Medicines and Healthcare products Regulatory Agency (MHRA).

Resources for the UK context:

DNA

Key UK Resources

A collection of key resources for gene and cell therapy developers in the UK context

Existing complementary work on developing ATMPs:

ATMP Sweden logo

ATMP Sweden

ATMP Sweden is a national network for activities on Advanced Therapy Medicinal Products (ATMPs).

ATMP Sweden has compiled supporting resources and reports regarding ATMP development. Learn more:

Restore project logo

Restore Project

The Restore project develops technologies that will enable the reproducible and economically feasible manufacturing of Advanced Therapies.

Read about the roadmaps, reports, factsheets produced by this project.

ABPI ATMP map

ABPI Resources

The Association of the British Pharmaceutical Industry (ABPI) has developed an ATMP roadmap, setting out the key steps in the end-to-end pathway for ATMPs in England from non-clinical research through to patient treatment & monitoring. Learn more about this roadmap and other relevant resources developed by ABPI:

ARM logo

ARM Project A-Gene

The Alliance for Regenerative Medicine (ARM) and partners have produced A-Gene, a case study-based guide to integrating Quality by design (QbD) principles in gene therapy Chemistry Manufacturing & Control (CMC) programs. Learn more about Project A-Gene and other resources published by ARM:

ATTC

ATTC Manufacturing and Preparation Toolkit

The Advanced Therapy Treatment Centres (ATTC) developed this toolkit to provide expert guidelines for manufacturing ATMPs. Learn more:

EJP RD logo

EJP RD Innovation Management Toolbox

EJP RD's searchable reference library of resources in rare disease translational medicine.

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