News & Articles

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 […]

Are you considering bringing your Chinese medicine products to Singapore? With a clear regulatory framework, zero registration fees, and swift evaluation timelines, Singapore presents an exciting opportunity for Chinese companies aiming to expand into Southeast Asia. Let’s explore the key differences in regulations between China and Singapore—and how The Reg Consultants (TRC) can guide your […]

Entering the pharmaceutical market in Singapore presents a complex web of regulations and requirements that companies must navigate. Market access refers to the process of making pharmaceutical products available to those who need them at the right price and time. The process involves various activities focused on ensuring patients receive the treatments they require. At […]