News & Articles

Cosmetic products are substances or mixtures intended for application to the external parts of the body, such as the skin, hair, nails, lips and teeth, for purposes including cleansing, perfuming, protecting or enhancing appearance. In Singapore, cosmetic products are regulated by the Health Sciences Authority and are subject to a mandatory cosmetic product notification prior […]

At present, health supplements in Singapore are not subject to pre-market approval prior to importation. While notification may be performed on a voluntary basis, companies often misinterpret this as an absence of regulatory requirements. In practice, this perception can be misleading. Companies importing health supplements remain fully responsible for ensuring that their products comply with […]

Registration of a medical product starts with an official classification  which will determine the documentary requirements, timelines, and fees. Today we are going to share a few misconceptions and the approach to classify a product correctly. Misconception We assume that the classification in the country of origin will be the classification in the country to […]

As pharmaceutical companies worldwide continue to expand their global reach, navigating the intricate landscape of international markets becomes an increasingly complex endeavour. In this era of heightened regulatory scrutiny, pharma companies must be well-versed in the multifaceted world of regulatory affairs in order to successfully expand their operations beyond borders. We’ll explore the indispensable role […]

What is a biosimilar? A biosimilar product is a biological therapeutic product demonstrated to be similar, in physicochemical characteristics, biological activity, safety and efficacy to an existing registered biological product.  The development of a biosimilar product places emphasis on the characterization of the reference’s Quality Target Product Profile  and performing comparability and safety studies to  […]

A generic product must have the same qualitative and quantitative composition in active ingredients and be of the same pharmaceutical form as a currently registered product in Singapore and shown to be bioequivalent to Singapore Reference Product (SRP). A marketing authorization application for a generic product fall under the application category of GDA-1 and GDA-2 […]