Cell and Gene Therapy

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The Cell and Gene Therapy Working Group was established in 2023 through the merger of the Cell Therapy Working Group and Gene Therapy Working Group. This regulator-only working group allows for the discussion of topics where regulatory policy is under development, with a focus on convergence of regulatory approaches within the confines of national regulations for advanced therapies.

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Members

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Members

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ANMAT, Argentina
ANVISA, Brazil
COFEPRIS, Mexico
CPED, Israel
EDA, Egypt
EMA, European Commission
FDA, United States
HC, Canada
HSA, Singapore
ISPCH, Chile
MHLW/PMDA, Japan
MFDS, Republic of Korea
MHRA, United Kingdom
MOH, Indonesia
NPRA, Malaysia
SAPHRA, South Africa
SFDA, Saudi Arabia
Swissmedic, Switzerland
TGA, Australia
TFDA, Chinese Taipei
Thai FDA, Thailand
TITCK, Türkiye

Observers:

PAHO/PANDRA
WHO

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Members List

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CGTWG - Members and Observers List, dated 24 September 2024

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Scope (Mandate) and Objectives

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Scope (Mandate) and Objectives

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The Cell and Gene Therapy Working Group is a regulator-only working group with the following objectives:

Provide an open forum for discussion of cell and gene therapy products.
Retain knowledge of regulatory activities in participating regions
Identify Topics for regulatory convergence or harmonization.
When appropriate, propose topics to ICH for harmonisation

Products under discussion:

Cell therapy products:
- Gene-modified cells
- Viral vectors
- Oncolytic vectors
- Genetically modified bacterial vector-based gene therapy products
- Genome editing technologies
- Tissue engineered products
- Xenotransplantation products

Key Deliverables:

Post results of working group projects
Draft reflection papers on topics with potential for convergence or harmonization
Publish journal articles and white papers, when appropriate
Update information on the regulatory landscape of cell and gene therapy products (Framework Project)

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File(s)

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CTWG - Mandate Document, dated 17 October 2018

GTWG - Mandate Document, dated 17 October 2018

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Work Plan

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CGTWG - Work Plan, dated 16 October 2024

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Work in Progress

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Work in Progress

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The working group has an on-going project, “Framework Project” which consists of a list of regulations, guidance documents, reflection papers and guidelines, and a list of approved products in participating regions. This project will be updated as needed and is considered a living document.