Regulatory overview of active ingredients

What are active ingredients?

Active ingredients, commonly known as Active Pharmaceutical Ingredients (API), are defined as any substances or compounds that are usable in the manufacture of the following health products as a pharmacologically active constituent:

• Therapeutic Products

• Cell, Tissue or Gene Therapy Products (CTGTP) that are more than minimally manipulated cell or tissues

• Medical Devices

The following substances are not considered active ingredients:

1. Multipotent stem cells which require further differentiation into pharmacologically active cells

2. Viral vectors used for ex vivo genetic modification of cells

3. Cell banks which require more than minimal manipulation before formulation into a CTGTP or used for production of a therapeutic product

Legislation

We regulate active ingredients in Singapore under the Health Products Act (HPA) and its regulations, including the Health Products (Active Ingredients) Regulations 2023.

Scope of regulation

We require companies to obtain licences before manufacturing, importing or wholesaling active ingredients. We will assess if you meet Good Distribution Practice and Good Manufacturing Practice standards before issuing your licence.