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Cell, tissue, gene therapy product (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. CTGTP products are divided into 2 classes namely: Class 1 CTGTP product […]

Cosmetic products are substances or mixtures designed for use on the external parts of the body, such as the skin, hair, nails, lips, and teeth, for the purpose of cleansing, perfuming, protecting, or enhancing appearance. In Singapore, all cosmetic products must comply with safety regulations and require a cosmetic product notification before they can be […]

At the current moment, Health Supplements are not subjected to registration prior to importation. Notification is on a voluntary basis. There may be advantage for you to execute the notification of the health supplements from a commercial perspective and it is always to be pro-active to adapt to the existing regulations rather than to rush […]

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 […]

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 radiopharmaceutical drug is defined as a radioactive pharmaceutical agent that is used for diagnostic or therapeutic procedures. A radiopharmaceutical consists of a drug component and a radioactive component.  Current registered radiopharmaceutical product in Singapore includes but not limited to :  Sodium pertechnetate (99mTc),           Sodium Molybdate(99Mo), RADIUM-223 CHLORIDE, Sodium Iodide [I-131] . Just like […]