The Gene Therapy Working Group (GTWG)’s objective is to discuss emerging scientific developments and concerns for the regulation of Gene Therapy (GT) products and to share regional updates in guidelines, science, and regulation of GT products.
1. General considerations
Background: The field of gene therapy is undergoing rapid scientific and clinical innovation worldwide. The Gene Therapy Discussion Group (GTDG) within the ICH framework was initially established in 2000 in an effort to prospectively work towards harmonization in an emerging product field rather than undertake the more difficult exercise of harmonization after regional policies and guidance documents were in place.
The GTDG produced three ICH considerations papers in an attempt to put forth harmonizing principles for gene therapy topics. In 2009, the M6 Expert Working Group (EWG) was formed to write an ICH guideline on virus/vector shedding. Due to insufficient fielding of representatives from the full ICH Steering Committee membership, the GTDG and M6 EWG were discontinued. However, the number of gene therapy clinical trials conducted worldwide has not diminished and the numbers of reported breakthroughs in the field of gene therapy have increased.
Since the ICH GTDG is no longer operating under the conventional ICH mechanism, FDA proposed that an alternative venue to engage global regulators in the area of gene therapy products be considered. On 11 October 2012, 9 members of the global regulatory community including Brazil ANVISA, European Medicines Agency (EMA), Health Canada, India National Institute of Biologicals (NIB), Japan Ministry of Health, Welfare and Labour/Pharmaceutical and Medical Devices Agency, South Korea Ministry of Food and Drug Safety (previously known as Food and Drug Administration (KFDA)), Singapore Health Sciences Authority (HSA), Swissmedic, and U.S. Food and Drug Administration convened via teleconference.
The Agencies agreed to establish the Regulators Forum Gene Therapy Discussion Group (RFGTDG), allowing the continuation of the ICH GTDG’s activities in an adapted form. With the integration of the RFGTDG into the IPRP organization, the name of the group was changed to the IPRP GT Working Group (IPRP GTWG).
During the first meeting it was established that the objective of the group would be to maintain the international networking forum in order to discuss emerging scientific developments and concerns for the regulation of GT products and to share regional updates in guidelines, science, and regulation of GT products.
- Non-proprietary information regarding regulatory experiences with GT products including focused topic discussions to enable sharing of views and regulatory best practices among international regulators.
- Topics that with adequate rationalization are potentially suitable for regulatory convergence or harmonisation
International regulators, including regulators from Australian TGA, Brazil ANVISA, EMA, Chinese Taipei, Health Canada, Japan (PMDA/MHLW), Korea MFDS, Singapore HSA, Swissmedic, US FDA, India (Indian Council of Medical Research), Thai FDA.
Work plan to be published soon.