The comments, which reference the ISSCR Guidelines (Recommendation 3.5.1) that urge national governments to “maintain rigorous review pathways to ensure that stem cell-based products conform to the highest standards of evidence-based medicine” are concerned that ANVISA’s proposed conditional marketing authorization (Chapter VI) fails to meet that standard and will allow products to be marketed to patients without adequate testing of safety and effectiveness.
Among the concerns addressed in the comments are:
- That ANVISA harmonize the proposed regulations with the evolving international standards such as those from the European Medicines Agency and the US Food and Drug Administration
- To regulate minimally manipulated somatic cell therapy products for non-homologous uses (Class I products) as rigorously as Class II products
- Clarify the definition for minimal and extensive manipulation of cellular products
The ISSCR has submitted comments on regulatory policies from countries across the globe and advocates for responsible regulation of stem cell- and cell therapy-based products.
These comments were submitted on 10 October 2019.