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Singapore is a strategic hub for companies seeking entry into ASEAN markets. Its strong regulatory framework, participation in mutual recognition arrangements, and efficient licensing processes provide a clear pathway to compliance. By leveraging Singapore’s position and working with a regulatory affairs consultant, businesses can align with ASEAN regulations and plan effective regional product launch strategies.

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 […]

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 […]