International – WHO charts path to convergence on cell and gene therapies

The World Health Organization (WHO) has issued a white paper for consultation that proposes a risk-based framework for regulating cell and gene therapy products (CGTPs) to promote global convergence among health authorities.

It proposes that autologous human cell and tissue (HCT) products for medical use be accorded a lower level of regulatory control than advanced therapy medical products (ATMPs), such as cell and gene therapies or tissue engineering products.

The paper’s goal is to “outline the fundamental principles that are important for providing adequate regulatory oversight for different types of CGTPs and should be reviewed in that context. In the future, WHO plans to develop more comprehensive written guidance, as needed, on specific topics relevant to regulation of CGTPs.”…