News & Articles

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, […]

Navigating Special Purpose Food Registration in Singapore Special purpose food plays a vital role in catering to individuals with unique dietary needs. According to the Food Regulations, Section 247 Clause, special purpose food is defined as food named or described as particularly suitable for consumption by persons belonging to a specific class who require a […]