The International Society for Cell and Gene Therapy (ISCT) published a watchdog report authored by IMPACT center of excellence’s and Cells for Cells’ leadership on the challenges facing therapeutic developers in Latin America against unregulated products. The Telegraft is the Society’s bi-monthly global cell and gene therapy (CGT) newsletter featuring updates on new science, industry, and regulatory news from the global community. The commentary was authored by María Ignacia Cádiz, MSc, Head of cGMP, and Dr. Fernando Figueroa, MD, Co-founder of Cells for Cells and lead PI at IMPACT, the center for Interventional Medicine for Precision and Advanced Cellular Therapy, affiliated to Universidad de Los Andes (Chile). Both authors are part of ISCT’s regional LRA (legal and regulatory affairs). Their viewpoint appeared on the South & Central America Legal and Regulatory Affairs Watchdog titled “The Challenge of Unregulated Regenerative Medicine – A Latin American Perspective.”
The analysis by Cádiz and Figueroa highlights the need for higher quality standards in the region, as two-thirds of the countries do not have specific regulations for regenerative medicine. The challenges this issue brings are associated with the presence of “products” on the market that could pose a severe risk to patients. To help address this matter, the authors compiled a list of the existing (and non-existing) legal and regulatory frameworks for developing, validating, and approving regenerative medicine products in 20 South and Central American countries, including Chile. They describe the situation in the Andean nation as a “patchwork legislation” with no specific reference to ATMPs, but also highlight the effort by the Chilean Institute of Public Health (ISP) in issuing “a first and promising Technical Guide for Biological therapies, based on the recommendations of the World Health Organization (WHO).”
The perspective featured by ISCT is part of IMPACT and Cells for Cells’ advocacy work to promote the creation of local and regional legislation that could facilitate world-class biomedical innovation in Latin America. Moreover, the commentary reaffirms the company’s pledge to advance safe and effective therapeutic products, supported by preclinical and clinical trial results conducted according to the highest international standards.
Link to commentary:
