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:
The following substances are not considered active ingredients:
a) Multipotent stem cells which require further differentiation into pharmacologically active cells
b) Viral vectors used for ex vivo genetic modification of cells
c) Cell banks which require more than minimal manipulation before formulation into a CTGTP or used for production of a therapeutic product
Effective from 18 December 2023, active ingredients are regulated under the Health Products Act and its regulations, including the Health Products Act (Active Ingredients) Regulations 2023. The Poisons Act and its Rules would no longer apply to active ingredients, henceforth.