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Considerations to Support Global Regulatory Harmonization and Access of Cell and Gene Therapy Products to Patients


This event is a complementary on-demand promotional webinar associated with the DIA 2024 Global Annual Meeting and open to the public.

Increasing the global availability of cell and gene therapy products is key to our patients. Understanding the unique clinical, non-clinical and CMC aspects of these products is crucial for harmonization and facilitating regulatory reliance.

Cell and gene therapy (CGT) products have the potential to revolutionize medical treatment and the landscape is rapidly evolving. Understanding the unique considerations for these products are key to advance the field and boost global harmonization of regulatory requirements, which ultimately will enable global access to these products.

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has formed the ICH CGT-Discussion group (ICH CGT DG) to address regulatory challenges specific to these products. This group aims to develop recommendations that will provide a common framework for the development and regulations of these therapies. During this session, the status and thinking on the roadmap that will guide global harmonization of technical requirements to support CGT product development will be shared.

Comparability assessments for CGT are crucial to ensuring that any changes made during development, manufacturing or post-approval phases do not negatively impact the products’ safety, efficacy, or quality. The development of these therapies presents unique challenges, and their complexity has the potential for impacting patient outcomes when changes are introduced. During this session, a presentation will be delivered focusing on the comparability requirements for CGTs, with the objective of generating a dialogue about the challenges they pose, and strategies employed.

Unique clinical and non-clinical considerations for CGTs influence the challenges and opportunities for their development. The modality, mechanism of action, route of administration, and therapeutic indication for a CGT product should influence the strategy for clinical and non-clinical development. In addition, this session will feature a presentation on unique clinical and non-clinical considerations for CGT products. The objective is to foster a discussion regarding strategies to overcome challenges and capitalize on the opportunities.

Please also check out DIA’s 2024 Global Annual Meeting taking place June 16-20, 2024!


  • Identify the status of the ICH Cell and Gene Therapies Discussion Group (CGT DG) and opportunities for harmonization and regulatory reliance
  • Learn about current regulatory requirements for comparability for cell and gene therapy products and the challenges they present for this therapeutic modality
  • Identify unique clinical and non-clinical considerations for cell and gene therapy products
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