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Navigating the complexities of therapeutic product licences in Singapore is important for pharmaceutical and medical device businesses to maintain regulatory compliance. When there are changes to a product’s safety, efficacy, quality, or forensic classification changes after registration of the pharmaceutical products, understanding the process and requirements for licence variations becomes crucial. This guide offers an […]

  Product Registrant Responsibilities In Singapore, the Marketing Authorization Holder (MAH), also known as the Product Registrant, is responsible for ensuring that products released into the market are safe and of high quality. This obligation includes pharmacovigilance (PV) activities such as monitoring safety profiles, adverse event reporting, active surveillance programs, and compiling Periodic Benefit-Risk Evaluation […]

Have you ever wondered what the difference between the terms “biosimilar” and “generic drugs” is? In the pharmaceutical industry, the distinctions between biosimilar and generic drugs play an important role in affecting healthcare accessibility and affordability, particularly in the context of pharmaceutical product registration. This guide explores the contrasting regulatory frameworks for biosimilars and generics, […]

  All overseas manufacturing sites are subjected to GMP conformity assessment by the local authority. GMP conformity assessment is in support a therapeutic product registration. Only local registered entity in Singapore can support the GMP conformity assessment application. The cost and timeline is dependent on the pathway in accordance to the pathway.   What is […]

As pharmaceutical products directly impact patient health and well-being, maintaining high-quality standards is essential. Medications should always be safe, effective and consistent in their therapeutic effects to avoid potential risks such as treatment failures, adverse reactions or even life-threatening consequences.  This is where Good Distribution Practice (GDP) for pharmaceutical products comes in handy, guaranteeing the […]

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 […]