News & Articles

In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore […]

China’s primary regulatory authority is the National Medical Products Administration (NMPA). The pharmaceutical landscape continues to evolve globally, with different countries adopting distinct approaches to ensure the safety, quality, and efficacy of medicinal products. China and Singapore are both dynamic markets with growing demand for innovative therapies. However, their regulatory environments differ significantly and can […]

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 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, […]