News & Articles

Cell and gene therapy is reshaping modern medicine, but entering Singapore’s market requires careful navigation of regulatory requirements. This article explores HSA’s framework for cell, tissue, and gene therapy products (CTGTPs), submission pathways, dossier requirements, and post-market obligations. Learn how biotech innovators can avoid delays and streamline approvals with the right strategies and expert regulatory support.

A successful generic drug application in Singapore depends on meticulous planning, dossier quality, and timely responses to regulatory queries. In this article, we explore the steps companies must take to improve their approval chances, reduce costly delays, and meet key HSA requirements. We also highlight the value of expert support in navigating the process effectively.

Standing out in Singapore’s crowded health supplement industry requires more than quality products. Voluntary HSA notification demonstrates safety, compliance, and transparency, all of which are values that retailers and consumers demand. This article explores how early notification builds authority, eases retail entry, and safeguards your business against future regulation, helping your brand thrive in the fast-growing wellness sector.

Singapore’s TCM market is growing, but strict HSA requirements make compliance essential. In this guide, we break down everything Chinese companies need to know about classification, licensing, labelling, and post-market obligations. Learn how to avoid missteps and ensure your Chinese proprietary medicine is safe, compliant, and ready for successful entry into the highly regulated healthcare landscape in Singapore

Registering pharmaceutical products in Singapore requires more than ticking boxes. In this article, we provide valuable tips and practical insights for building a strategic pharmaceutical registration roadmap, covering pathway selection, pre-submission planning, and post-market responsibilities. Learn how to reduce risks, streamline approvals, and maintain compliance with structured steps designed to support sustainable long-term market access.

In Singapore, regulatory submissions cannot move forward without a local authorised representative. A regulatory consultant fills this role, serving as a liaison with HSA, preventing costly errors, and managing ongoing compliance. The result? Stronger approval success, faster timelines, and peace of mind for international manufacturers entering the Singapore healthcare and pharmaceutical market. Keep reading to learn more.