Guidance related to ATMPs

Part IV - Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products - Incorporated into current Orange Guide

MHRA Guidance

ATMP Classification flowchart

Advanced therapy medicinal products advice form

Guidance on the UK’s arrangements under the hospital exemption scheme

Guidance on “non-routine” ATMPs

Points to consider for trials allowing inclusion of patients previously treated with an Advanced Therapy Medicinal Product (CAR-T cells, gene therapy, tumour vaccines)

British Pharmacopoeia Guidance

British Pharmacopoeia ATMP Best Practice Guidance - Requires entering contact details to download.

EU Guidance - General

EMA Reflection paper on classification of advanced therapy medicinal products

EU Guidance - Technical

Guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

Guideline on human cell-based medicinal products

Guideline on potency testing of cell based immunotherapy medicinal products for treatment of cancer

Guideline for Xenogeneic cell therapy

Guideline on Development and Manufacture of Lentiviral vector

Guideline on the Non-Clinical Studies Required before First Clinical Use of Gene Therapy Medicinal Products

Guideline on nonclinical testing for inadvertent germline transmission of Gebe transfer vectors

Guideline on Clinical follow-up gene therapy

Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products

Guideline on Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products

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