News & Articles

Accessing life-saving treatments can be challenging, particularly for those living with rare diseases. In Singapore, as in many other regions, orphan drugs — medications specifically created to treat these rare conditions — come with unique challenges regarding availability and cost. In this guide, we delve into the complex issues surrounding orphan drugs and offer a […]

The medical device sector in Singapore has experienced remarkable growth, driven by the nation’s favourable business environment, robust intellectual property protections, and expanding healthcare demands. However, navigating the high standards and stringent regulatory requirements can be challenging. A thorough understanding of the medical device registration process, together with guidance on HSA registration and regulatory support, […]

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 […]

As standards of living and healthcare quality rise, the demand for pharmaceuticals, medical devices, and other medical commodities, collectively called health products, is on the rise. With more products entering the market, it’s vital to have robust regulatory systems in place to ensure timely access to safe and effective therapies. Strengthening the registration framework is […]

  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, […]