News & Articles

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 […]

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 […]

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 […]