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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 […]

A Marketing Authorization Holder (MAH) is a local company that is assigned by the Manufacturer to be in charge of all licensing matters.

Does your pharmaceutical company require help complying with regulatory guidelines? Regulatory service providers can provide great assistance

Regulatory intelligence as defined in TRC’s understanding is market research on regulations with the following objectives in mind:  To obtain the most accurate information concerning pathway , application type , requirements , timelines, and fees of the pharmaceutical or medical products to be registered  Impact of a certain regulations on existing pipeline of products  The feasibility of using existing dossier to apply for marketing authorization in the territory of interest  Get a framework of how a certain product is regulated in a certain market as a global regulatory strategy  To examine a potential question e.g a lack of certain documents such as not having PIC/S GMP or not meeting certain criteria e,g not having Zone IVb stability data which is essential in ASEAN countries or not having prior approval in reference agencies of the territory could be critical for registration in the case of biosimilars