Product classification and screening
We review your product to determine the correct HSA classification (prescription, OTC, generic, or health supplement) and the appropriate registration route.
HSA therapeutic product registration for overseas manufacturers, managed end-to-end by a Singapore-registered regulatory partner.
INNORINI PTE. LTD. (UEN 202015523Z) provides HSA drug registration services in Singapore for overseas pharmaceutical companies. We act as the local product registrant, preparing and submitting regulatory dossiers to the Health Sciences Authority (HSA), managing evaluation queries, and handling post-market compliance. Our team supports registration of prescription, OTC and generic medicines, and voluntary HSA notification for health supplements, with manufacturing through our qualified GMP manufacturing partners.
At a glance
Yes. A foreign pharmaceutical company can register a therapeutic product in Singapore, but the registration must be held by a Singapore-registered entity acting as the local product registrant or sponsor. Innorini Pte Ltd can act as your local registration holder, managing the entire HSA submission process from our Clementi facility.
This model allows overseas manufacturers to access the Singapore market without establishing a local subsidiary, while benefiting from the regulatory credibility of a Singapore-registered company with HSA import and wholesale capabilities.
| Local registrant | INNORINI PTE. LTD. (UEN 202015523Z) |
|---|---|
| Regulator | Health Sciences Authority (HSA), Singapore |
| Product types | Prescription (POM), OTC and generic medicines; health supplements by voluntary notification |
| Dossier format | ICH CTD or ASEAN CTD (ACTD) |
| Manufacturing partner | GMP-certified manufacturing partners |
| Additional services | Import licence, label compliance, post-market, variations, renewals |
| Contact | sales@innorini.com.sg |
We review your product to determine the correct HSA classification (prescription, OTC, generic, or health supplement) and the appropriate registration route.
We assess your existing documentation against HSA requirements, identify gaps, and compile the full CTD-format dossier including quality, non-clinical, and clinical data.
We submit the application through HSA's PRISM system, paying the applicable fees and managing the initial screening process.
During HSA's evaluation period, we respond to all queries and requests for additional information, coordinating with your manufacturing and technical teams as needed.
Upon approval, we finalise the product licence, label artwork, and import requirements. We can also handle the first import shipment and customs clearance.
We manage ongoing post-market responsibilities including variations, renewals, adverse event reporting, and regulatory updates as required by HSA.
HSA evaluation timelines vary significantly by product type, complexity, and evaluation route. The table below summarises the main evaluation pathways available for therapeutic products in Singapore.
| Evaluation Route | Eligibility | Indicative Timeline |
|---|---|---|
| Full Evaluation | New chemical entities, products with no prior reference agency approval | Up to 270 working days |
| Abridged Evaluation | Approved by at least one drug regulatory agency | New drug: 180 working days; generic: 240 |
| Verification Evaluation | Approved by HSA reference agencies (FDA, EMA, Health Canada, UK MHRA, Swissmedic, TGA): two for a new drug, one for a generic | New drug: 60 working days; generic: 120 |
Timelines are indicative and exclude time taken by the applicant to respond to HSA queries. Refer to hsa.gov.sg for current official timelines and fees.
Innorini provides a realistic timeline assessment after reviewing your product documentation, including which evaluation route your product qualifies for.
Under HSA regulations, therapeutic products are classified based on their level of professional supervision required for supply. The classification determines the registration requirements, labelling, and channels of distribution.
| Classification | Description | Supply Channel |
|---|---|---|
| Prescription-Only Medicine (POM) | Requires a doctor's prescription; full dossier and HSA approval | Hospitals, clinics, pharmacies with prescription |
| Pharmacy-Only Medicine (P) | Can be supplied by a pharmacist without a prescription | Retail pharmacies under pharmacist supervision |
| General Sale List (GSL) | Considered safe for self-selection and public sale | Pharmacies, supermarkets, general retail |
| Over-the-Counter (OTC) | Non-prescription products; classification supported by reference agency documentation | Pharmacies and approved retail outlets |
| Biologicals / Biosimilars | Subject to detailed comparability and stepwise non-clinical/clinical evaluation | Hospitals, specialty clinics |
| Controlled Drugs | Regulated under the Misuse of Drugs Act; require special licences and controls | Licensed institutions only |
| Chinese Proprietary Medicines (CPM) | Separate product listing requirements under CPM guidelines | TCM clinics, pharmacies, designated retailers |
Singapore's pharmaceutical market is one of the most advanced in Asia-Pacific, governed by internationally harmonised frameworks aligned with ICH, PIC/S, and ASEAN guidelines. HSA was one of the first three regulators worldwide to be designated a WHO-Listed Authority for medicines (October 2023).
Singapore serves as a regulatory gateway to Southeast Asia. HSA accepts dossiers in ICH CTD or ASEAN CTD format, so the core dossier can be adapted for other ASEAN regulators. English is the working language, and Singapore's legal and IP framework provides strong protection for pharmaceutical innovators.
For overseas manufacturers, registering in Singapore through a local partner like Innorini provides a credible entry point into the broader SEA market of over 660 million people.