News & Articles

We’re back for our weekly deep dive into the fascinating world of regulatory affairs! This week, I want to tackle a topic that comes up surprisingly often in my conversations with clients, especially those looking to bring life-saving products like vaccines to new markets: How do you leverage a WHO Prequalified (PQ) dossier for registration […]

Amongst the ever-emerging trend of new generation drugs, there is a group that is not widely discussed yet still remains the gold standard of treatment — or even serves as the pharmacophore on which many modern drugs are built. Examples of grandfather products include aspirin, morphine, diphenhydramine, and propranolol — all introduced decades ago and […]

Biologics submissions are often more complex than small molecule applications, not just due to the science but because of the higher regulatory scrutiny involved. In Singapore, HSA’s review of biologics focuses heavily on product quality, clinical safety, and manufacturing consistency. At TRC, we’ve supported multiple clients preparing or refining their Common Technical Document (CTD) dossiers […]

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, […]

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 […]