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:
- Recombinant vaccines for a preventive purpose. Such products are typically considered therapeutic products instead.
- In-vitro diagnostic products. Such products are typically considered medical devices instead.
- Cells and tissues obtained from a patient that are minimally manipulated and reimplanted into the same patient for homologous use during the same surgical procedure (e.g., coronary artery bypass graft)
- Bone marrow, peripheral blood or umbilical or placental cord blood from a human that is minimally manipulated and intended for homologous use
- Organs and tissues that are minimally manipulated and intended for transplant
- Reproductive cells (sperm, eggs) and embryos intended for assisted reproduction
- Whole blood any blood component that is minimally manipulated and intended for treating blood loss or blood disorders
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^
- intended for homologous use*
- 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 for orthopaedic indications
- Scleral patch graft for ocular surgery
Examples of Class 2 CTGTP:
- Gene modified cells
- Cells grown on scaffold
- Culture expanded cells
- Vectors with therapeutic gene
^Minimally manipulated refers to any processing of the cell or tissue stated below that does not alter the cell's biological characteristics or functions, or the tissue's structural properties: cutting or sizing, grinding, shaping, centrifugation, soaking in an antibiotic or antimicrobial solution, sterilisation or irradiation, cell separation, concentration or purification, filtration, lyophilisation, freezing, cryopreservation or vitrification.
*Homologous use refers to using the CTGTP to repair, reconstruct, replace or supplement the cells or tissues of the recipient to perform the same basic function(s) as the original cells and tissue in the donor in the same anatomical or histological environment. E.g., bone grafts for orthopaedic indications.