With an advanced healthcare system, Singapore is regarded as a key drug market by renowned global pharmaceutical companies. Medicinal products in Singapore are regulated by the Health Science Authority (HSA) under Health Products Act 2007, and they must obtain necessary approvals to be distributed and marketed in the country. For innovator products, a New Drug Application (NDA) should be filed and for generic drugs, it should be a Generic Drug Application (GDA) application. All applications to the HSA must be filed or submitted through the Pharma Regulatory and Information System (PRISM). Right from compiling dossiers as per pre-defined formats, assessing ingredient limits to handling submissions through established systems, new market entrants may find it difficult to navigate the country’s Regulatory procedures.
With a dedicated team for Singapore, Freyr ensures compliance by liaising with the HSA during pre- and post-submission activities. Freyr specializes in handling dossier compilation and submission as per ACTD/ eCTD formats in line with HSA requirements. Freyr also aids in responding to HA queries, renewals and other post-approval activities to maintain continued compliance.
- Regulatory consultation during the development of the medicinal products like designing of specifications, establishing limits for genotoxic, elemental impurities and review of protocols/reports for process validation, stability, exhibit batches and analytical method validation
- Regulatory submission road map for medicinal product registration in Singapore
- Expert team for handling PRISM for all kind of Regulatory submissions to the HSA
- Pre-submission administrative activities, pre-submission interaction with health authorities
- Evaluation of the product source data from R&D and manufacturing site (executed data)
- Compilation and submission of the dossiers to HSA in ACTD/eCTD format
- Act as Product License Holder (PLR), Batch Releaser, Corporate or legal entity in Singapore
- Post-approval changes submission with strategy and compilation of variation packages
- Change control evaluation and compliance activities
- Preparation of strategy and response document for HSA queries
- Filing renewal application through PRISM, two months ahead of the expiry of product license