In Singapore, the regulation of nutraceuticals and dietary supplements is stringent to ensure the safety, quality, and efficacy of these health products. Understanding the regulatory framework, the registration process, and associated costs is crucial for businesses looking to bring nutraceuticals to the Singaporean market. It is expected that the Singapore nutraceutical industry revenue will reach 1.6 billion SGD by 2023 end. With the ageing population in Singapore the demand for bone and heart health products are on steep rise and the same is augmented by the urban lifestyle and passion for sports. It is observed that nutraceutical market in Singapore is in its late growth stage. The market is expected to register a positive CAGR (compounded annual growth rate) of 3.4% in terms of revenue during the forecast period 2018-2023.
Nutraceutical Regulatory framework in Singapore.
In Singapore, the regulation of nutraceuticals and dietary supplements primarily falls under the Health Sciences Authority (HSA), which is responsible for ensuring the safety, efficacy, and quality of health products, including nutraceuticals.
Product Classification: The HSA classifies health products, including nutraceuticals and dietary supplements, based on their ingredients, intended use, and safety profiles. Products may be categorized as "General Sale" or "Pharmacy Only," depending on their risk profile.
Licensing and Registration: Manufacturers, importers, and distributors of nutraceuticals and dietary supplements must obtain appropriate licenses or registrations from the HSA before marketing and selling these products in Singapore.
Good Manufacturing Practices (GMP): GMP guidelines are international quality standards that ensure the consistency, quality, and safety of the products. The HSA may conduct inspections of manufacturing facilities to verify compliance.
Nutraceutical registration in Singapore
1. Pre-Application Preparation:
Compliance Assessment: Before beginning the registration process, ensure that your nutraceutical product complies with Singapore's regulatory requirements.
Choose a Local Responsible Person (LRP): If your company is based outside of Singapore, you must appoint an LRP who is a resident of Singapore and will liaise with the HSA on your behalf.
2. Application Submission:
Submit an application: Prepare and submit an application for the registration of your nutraceutical product through the HSA's online portal.
3. Document Submission:
Product Information: Provide detailed information about your product, including its formulation, ingredients, concentrations, and intended use.
Manufacturing Information: Submit details about the manufacturing facility, including adherence to Good Manufacturing Practices (GMP) standards.
Quality Control Measures: Include information on quality control procedures and testing methods to ensure the product's consistency and quality.
Safety Data: Provide scientific evidence supporting the safety of your product. Efficacy Data: If you make specific health claims about your product, submit scientific evidence demonstrating its efficacy.
Nutraceutical product Labeling and Packaging Requirements in Singapore
Nutraceuticals and dietary supplements must comply with specific labeling and packaging requirements set by the HSA. This includes providing accurate information about the product's ingredients, dosage instructions, potential side effects, and storage conditions. The HSA's guidelines help ensure that consumers have access to clear and truthful information about the products they purchase.
Health supplement product registration Timeline and fees associated in Singapore.
The time it takes for health supplement registration 6-12 months and it can be influenced by factors such as
Completeness of the Application.
Product Complexity.
HSA Workload.
Inspections.
Regulatory Changes
The application fee for nutraceutical product registration in Singapore is $106.
Nutraceutical Post-Market Surveillance: The HSA monitors the market for adverse events, product safety concerns, and non-compliance issues related to nutraceuticals and dietary supplements. Manufacturers and distributors are required to promptly report any adverse events associated with their products to the HSA.
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