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.

Singapore is moving toward eCTD submission as the standard for new drug, generic, and biologics applications. While the system promises efficiency, it also demands precision. In this article, discover how to avoid common errors, strengthen lifecycle management, and align with HSA and ICH standards to ensure smoother approvals, long-term compliance, and future regulatory readiness in Singapore.

The ASEAN pharmaceutical market is rapidly expanding, but fragmented regulations can delay product launches. In this comprehensive guide, we explore how harmonisation with the ACTD, centralised dossier management, and expert guidance help companies streamline submissions, reduce costs, and navigate country-specific requirements with ease. Unlock faster approvals, stronger compliance, and sustainable market access across the region’s dynamic healthcare landscape.

Many biologics licence applications stumble in Module 3, where CMC, stability, and quality data are closely scrutinised by the HSA. This article highlights frequent errors, their impact, and how to prevent them. With TRC’s pharma regulatory services and HSA support, we aim to help companies and marketing authorisation holders prepare accurate, compliant submissions that minimise queries and speed up approval.

For companies navigating new drug or biologics submissions, HSA pre-submission meetings are a strategic advantage. They clarify expectations, streamline timelines, and build confidence with regulators. Explore why these meetings matter and how The Reg Consultants, a trusted regulatory affairs consultant in Singapore, supports your team with guidance, preparation, and HSA registration expertise to achieve smooth approvals.