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Regulatory overview of cell, tissue or gene therapy products

Understand the scope of regulations of cell, tissue or gene therapy products in Singapore.

What are cell, tissue or gene therapy products (CTGTP)?

CTGTP are health products intended for use in humans for a therapeutic, preventive, palliative or diagnostic purpose. CTGTP can contain any of the following and achieves its primary intended action by pharmacological, immunological, physiological, metabolic or physical means:

  • viable or non-viable human cells or tissues
  • viable animal cells or tissues
  • recombinant nucleic acids

The following products are NOT considered CTGTP:

  1. Recombinant vaccines for a preventive purpose. Such products are typically considered therapeutic products instead.
  2. In-vitro diagnostic products
  3. Bone marrow, peripheral blood or umbilical or placental cord blood from a human that is minimally manipulated and intended for homologous use
  4. Cells and tissues obtained from a patient that are minimally manipulated and reimplanted for homologous use into the same patient during the same surgical procedure
  5. Organs and tissues that are minimally manipulated and intended for transplant
  6. Reproductive cells (sperm, eggs) and embryos intended for assisted reproduction
  7. Whole blood any blood component that is minimally manipulated and intended for treating blood loss or blood disorders

Legislation

We regulate therapeutic products in Singapore under the Health Products Act (HPA) and its regulations, including the Health Products (Cell, Tissue and Gene Therapy Products) Regulations 2021.

In Singapore, CTGTP are risk-stratified into two classes below:

Class 1 CTGTP (lower risk)

Class 2 CTGTP (higher risk)

CTGTP which satisfies ALL the following criteria:
  • minimally manipulated, i.e. biological characteristics or functions of the cell or the structural properties of the tissue are not altered
  • intended for homologous use (performing same function and administered at the same anatomical site or histological environment in the recipient as in the donor)
  • not combined or used in conjunction with therapeutic products or medical devices
Other CTGTP which are not classified as Class 1 CTGTP.

Examples of Class 1 CTGTP:

  • Bone grafts
  • Amniotic membrane
  • Skin

Examples of Class 2 CTGTP:

  • Gene modified cells
  • Cells grown on scaffold
  • Culture expanded cells
  • Vectors with therapeutic gene
  • Xeno-based products.

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