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Previously, drug substance manufacturers submitting applications for new drugs, generic drugs, or minor variations involving the introduction or change of a drug substance (DS) manufacturer were not required to provide GMP evidence. However, starting from October 1st, it is essential to note that GMP compliance evidence will be mandatory for these submissions in Singapore. This […]

Navigating the complex world of regulatory affairs is crucial for pharmaceutical and biotech companies looking to ensure compliance while speeding up pharma market access. In Singapore’s competitive landscape, the demand for customised regulatory management has led to the rise of subscription plans tailored to companies of all sizes, from startups to big pharma. These plans […]

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 seen significant growth recently, thanks to the country’s supportive business climate, strong intellectual property protections, and rising healthcare needs. However, the country is known for its high standards and strict requirements. Manufacturers need to thoroughly understand these protocols to ensure compliance and a smooth market entry when introducing […]

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 […]

In the wake of the COVID-19 pandemic, telehealth has become a transformative approach in healthcare, offering patients and providers new ways to connect and deliver care remotely. Initially, telehealth, also known as telemedicine, was primarily used for reviewing stable conditions that did not require physical examinations, such as mental health issues. It has since evolved […]