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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.

Scope of regulation

Clinical trials

Clinical trials involving Class 1 CTGTP are regulated under the Human Biomedical Research Act (HBRA) by the Ministry of Health. However, the manufacture, import and supply of CTGTP used as a clinical research material (CRM) in Singapore must comply with the regulations of CRM under the Health Products Act.

For Class 2 CTGTP, you may be required to apply for a Clinical Trial Authorisation or submit a Clinical Trial Notification to us before conducting the clinical trials in Singapore.

Product notification or registration

Before you can supply a CTGTP in Singapore, you will have to first:

Dealer's licensing or notification

Before you can import, manufacture and supply CTGTP in Singapore, you will need to first:

You will need to comply with Good Distribution Practice and Good Manufacturing Practice standards accordingly.

Variation application (registered CTGTP)

Submit a variation application to us when there is a change to your registered Class 2 CTGTP safety, efficacy or quality information.

Advertisement and sales promotion

You do not need to obtain prior approval from us before you advertise or promote your CTGTP.

However, you must comply with our regulations regarding advertising claims of CTGTP. Advertising and promotional messages should not contain misleading claims, lead to improper use of the product, or bring undue harm to the public.

Adverse events reporting

If the CTGTP you are marketing poses a serious threat to health, causes death, or undesirable effects, you must report the adverse event to us within a given time frame.

Product defect reporting

As a dealer or product registrant, you are responsible for the safety, quality and efficacy of your CTGTP, and must know how to report and recall defective products that may potentially cause harm to patients or the public.

Clinical trials
Product notification or registration
Dealer's licensing or notification
Variation application (registered CTGTP)
Advertisement and sales promotion
Adverse events reporting
Product defect reporting
Import, manufacture and wholesale of CTGTP

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