News & Articles

When companies prepare to register biologic products in Singapore, there’s a common assumption that all biologics must go through the NDA-1 route. But that’s not always the case. Understanding Singapore’s NDA-1, NDA-2, and NDA-3 categories — and which applies to your product — is key to smooth regulatory submissions and avoiding unexpected delays. NDA-1: New […]

Biologics in Singapore: What Makes the Dossier Different? If you’re looking to register a biologic product in Singapore, you might have noticed it’s not quite the same as other drugs. From my experience working with clients, the local authority has some specific expectations that make the dossier a bit different. The CTD format is familiar, […]

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 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 […]