News & Articles

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 […]

We often get leads from prospects telling us: “My product is FDA/EMA approved, so there shouldn’t be any issue for local submission. Efforts on your end should be minimal – can we reduce costs?” I’m sure those who know the reality are quietly laughing behind their screens as I say this. Why Do We Still […]

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 making post-approval changes to chemical drugs registered in Singapore, understanding which MIV-2 changes require a Notification vs Do-and-Tell under HSA’s guidance is crucial for smooth regulatory compliance. This distinction is explained in Annex 13B (MIV-2 Notification) and Annex 13C (MIV-2 Do and Tell) of the guidelines. What is an MIV-2 Change? MIV-2 refers to […]

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, […]