Singapore stands as a beacon of regulatory excellence in the pharmaceutical industry,
offering a robust framework that ensures the safety, efficacy, and quality of drugs in the market. Understanding the intricacies of drug regulation in Singapore is paramount for pharmaceutical companies aiming to navigate the market successfully. This whitepaper serves as a comprehensive guide to drug regulation in Singapore, providing insights into regulatory authorities, registration processes, and compliance requirements for New Drugs, Generics and Biosimilars. New Drugs, Generics and Biosimilar Registration in Singapore: Whitepaper on HSA Regulations
Overview of Regulatory Authorities for New Drug, Generics, Biosimilar Registration:
Health Sciences Authority (HSA): The primary regulatory body responsible for regulating pharmaceuticals, medical devices, and health products in Singapore. HSA ensures that drugs meet rigorous standards for safety, quality, and efficacy before they are marketed.
Drug Registration Process:
Pre-submission Consultation with HSA in Singapore (New Drug, Generic, Biosimilar Registration):
Companies are encouraged to engage in pre-submission consultations with HSA to clarify regulatory requirements and ensure smooth processing of applications. The timeline for this is 1-2 Months.
New Drug Application (NDA):
Detailed submission of data on the safety, efficacy, and quality of the drug, including preclinical and clinical trial data, chemistry, manufacturing, and controls (CMC), and labeling information
NDA 1 | NDA 2 | NDA 3 |
For the first strength of a product containing a new chemical or biological entity. | For the first strength of a product containing: • New combination of registered chemical or biological entities. • For the first strength of a biosimilar product with the same dosage form and route of administration as the Singapore reference biological product. | For subsequent strengths of a product that has been registered or has been submitted as a NDA-1 or NDA-2. The product name, dosage form, indication, dosing regimen and patient population should be the same as that for the NDA-2.
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Generics and Biosimilars:
Registration pathways for generic drugs and biosimilars, including requirements for bioequivalence studies and comparative analytical data.
GDA 1 | GDA 2 |
For the first strength of a generic chemical product. | For subsequent strengths of the generic chemical product that has been registered or submitted as GDA-1. The product name and dosage form should be the same as that for the GDA-1. |
Accelerated Approval: HSA offers expedited review processes for drugs addressing unmet medical needs or for life-threatening conditions.
Full NDA | Abridged NDA | Verification NDA | Abridged GDA | Verification GDA | Verification-CECA GDA |
Product that has not been approved by any country
| Product approved by at least one country
For Biosimilar: The product must be approved by at least one of reference agency: EU EMA, Australia TGA, UK MHRA, US FDA and Health Canada. | Product with similar indication(s), posology that have been approved by at least 2 HSA RA.
| Product approved by at least one country
| Product with similar indication(s), posology that have been approved by at least 1 HSA RA.
| Generic product manufactured in India approved by HSA’s RA,
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Good Manufacturing Practice (GMP) Compliance:
Manufacturers and importers of pharmaceutical products must adhere to stringent GMP standards to ensure the quality and consistency of drug manufacturing processes. Singapore follows PIC/s country guidelines, therefor, for a manufacturing site which is approved in one of the PIC/s countries, onsite audit shall not be required whereas for Non- PIC/s country, HSA might plan for an audit
Post-Market Surveillance and Pharmacovigilance:
Continuous monitoring of drug safety and efficacy through post-market surveillance activities, including adverse event reporting, product recalls, and risk assessment.
Pricing and Reimbursement:
The Singaporean government employs various mechanisms to ensure affordable access to essential drugs, including the Pharmaceutical Benefits Scheme (PBS) and the Medication Assistance Fund (MAF).
Timelines and Agency Fees:
The timeline for NDA submissions is approximately 6 months-24 months whereas for GDA 9 months-24 months based on the type of application submitted. The HSA fees varies for different application, For NDA, it is USD 5500- 15000, whereas for GDA, it is USD 2500-10000.
Navigating drug regulation in Singapore requires a deep understanding of regulatory processes, compliance requirements, and ongoing regulatory developments. By adhering to high standards of safety, quality, and efficacy, pharmaceutical companies can successfully bring innovative drugs to the Singaporean market, contributing to improved healthcare outcomes and patient well-being.
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Oindrila Ghosal | Vice President, Artixio Consulting | Oindrila Ghosal | LinkedIn |
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