The ICH Cell and Gene Therapy Discussion Group (CGTDG), established in May 2023, has just issued a paper, Recommendations with Regard to Future Advanced Therapy Medicinal Products-related Guidelines.<\/p>\n
There is a growing need for harmonisation on topics related to cell and gene therapy products, an emerging field with great promise in the treatment and cure of debilitating and life-threatening diseases.<\/p>\n
The CGTDG, which is comprised of experts drawn from 24 regulatory authorities, pharmaceutical industry organisations and Standing Observers, was established to develop a strategic framework to address future technical harmonisation needs in this field. The group first agreed on high-level principles on special considerations for advanced therapy medicinal products and then went on to develop a cell and gene therapy roadmap based on prioritised areas most in need of harmonisation, with specific recommendations for new or revised guidelines.<\/p>\n