News & Articles

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 […]

5 quick questions to check before regulatory filing of pharmaceutical products in ASEAN

In my previous blog, we shared briefly on 5 points to look out for when preparing a dossier for submission

If you are currently an overseas company having plans to get your manufacturing site to be (PIC/S) certified, Singapore is a best choice