The Health Sciences Authority (HSA) invites public feedback on the proposed regulation for cell, tissue and gene therapy products (CTGTP), a new category of health products. The public consultation will run from 6 November 2020 to 27 November 2020.
The area of CTGTP is a rapidly evolving field where cells and tissues can be engineered to grow healthy and functional tissues to reconstruct, regenerate or repair damaged tissues or organs, or where new genes are introduced into the body to treat or cure diseases. CTGTP has the potential to transform the current practice of medicine and offer potential cures for chronic and debilitating diseases. HSA is proposing to include the new category of CTGTP in the First Schedule to the Health Products Act.
The regulation of CTGTP will:
(i) facilitate patients’ access to medically important therapies that meet the appropriate standards of safety, efficacy and quality; and
(ii) provide a fit-for-purpose regulatory framework that supports product development and facilitates product commercialisation.
The key proposed regulations include:
Definition of ‘CTGTP’ based on the presence of stem cells, tissues and genes, and their purpose;
Risk-based regulatory approach for product registration and dealer licensing, based on the degree of manipulation (minimal or more than minimal), intended use (homologous or non-homologous use) and whether it is a combination product (whether combined with medical devices or therapeutic products), with Class 1 CTGTP being lower risk, and Class 2 CTGTP being higher risk;
Requirements that are unique to CTGTP include having a traceability system to enable bi-directional tracking of CTGTP from its source up to the administration of the product to the patient and vice versa, and maintaining the records of traceability for 30 years after the expiry of the product.
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