A complete step-by-step guide to HSA therapeutic product registration, from classification to approval and post-market compliance.
Registering a therapeutic product in Singapore requires submitting a CTD-format dossier to the Health Sciences Authority (HSA) through a locally registered product registrant. The process involves product classification, dossier preparation, evaluation route selection, HSA submission via PRISM, query management, and post-market compliance. Timelines range from 60 working days (verification route) to 270 working days (full evaluation), depending on whether your product is already approved by reference agencies.
Not all health products require HSA therapeutic product registration. The first step is to determine your product's regulatory classification:
| Product Type | Regulatory Pathway | Registration Required? |
|---|---|---|
| Prescription medicine (POM) | Therapeutic product registration | Yes - full HSA approval |
| Pharmacy-only medicine (P) | Therapeutic product registration | Yes - HSA approval |
| General sale list (GSL) | Therapeutic product registration | Yes - HSA approval |
| Over-the-counter (OTC) | Therapeutic product registration | Yes - with reference agency support |
| Health supplement | Voluntary notification scheme | No. HSA notification is voluntary |
| Topical antiseptic | Exempt (certain products) | May be exempt - verify with HSA |
| Chinese proprietary medicine (CPM) | CPM listing | Yes - separate CPM framework |
| Medical device | SMDR registration | Yes - separate device framework |
If you are unsure about your product's classification, Innorini can provide a regulatory classification assessment based on your product's ingredients, claims, and intended use.
HSA requires that therapeutic product registrations be held by a Singapore-registered entity. Foreign manufacturers cannot hold the registration directly. You have two options:
The local registrant is responsible for the HSA submission, import licence, post-market compliance, and pharmacovigilance. Innorini can act as your local registrant for products we manufacture or distribute.
HSA accepts dossiers in ASEAN CTD (ACTD) or ICH CTD format. The dossier must include:
| Module | Content |
|---|---|
| Module 1 | Administrative information, labelling, package insert, local registrant details |
| Module 2 | Quality overall summary, non-clinical and clinical overview |
| Module 3 | Quality documentation: drug substance, drug product, manufacturing, controls, stability |
| Module 4 | Non-clinical study reports (pharmacology, toxicology, pharmacokinetics) |
| Module 5 | Clinical study reports (bioequivalence, clinical efficacy and safety) |
Key supporting documents include: manufacturer's GMP certificate, site master file, certificates of analysis, stability data (accelerated and long-term), proposed labelling and artwork, and a quality agreement between manufacturer and registrant.
For generic products, bioequivalence studies are typically required unless biowaiver criteria are met. Products already approved by HSA’s reference agencies (FDA, EMA, Health Canada, UK MHRA, Swissmedic, TGA) may qualify for the faster verification route.
HSA uses three evaluation routes for therapeutic products. The route sets the depth of review and HSA’s target timeline:
| Route | Eligibility | Indicative Timeline |
|---|---|---|
| Full Evaluation | New products not approved by any drug regulatory agency (new drugs only) | 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 |
Targets run from acceptance for evaluation. Screening (up to 50 working days) and the time you take to answer HSA queries come on top. Source: HSA fees and turnaround times.
All HSA therapeutic product submissions are made through the PRISM (Pharmaceutical Regulatory Information System) e-portal. The submission process includes:
Innorini manages the entire PRISM submission process for our partner products, including account setup, dossier upload, fee payment, and screening response.
During evaluation, HSA typically issues queries requesting additional information, clarification, or data. Common query areas include:
Prompt, complete responses to queries are critical to avoiding delays. Innorini coordinates with your manufacturing and technical teams to prepare comprehensive query responses.
Upon successful evaluation, HSA issues a Certificate of Registration (product licence) with a 5-year validity period. The product is listed in the Singapore Register of Therapeutic Products (SRTP). After approval, you will need to:
Registration is not the end of the process. Post-market obligations include:
| Requirement | Description | Frequency |
|---|---|---|
| Adverse event reporting | Report adverse drug reactions to HSA | Ongoing, within specified timelines |
| Variations | Prior approval for changes to formulation, site, labelling, or specifications | As changes occur |
| Retention fee | Pay HSA’s annual retention fee to keep the product on the register | Every year, on the registration anniversary |
| Periodic safety reports | PSUR/PBRER submissions as required | Per HSA schedule |
| GMP compliance | Maintain manufacturing site GMP compliance | Ongoing |
| Recall management | Maintain recall procedures and notify HSA if needed | As needed |
The total timeline depends on the evaluation route and the completeness of your dossier:
We give you a project timeline after reviewing your dossier, because the biggest variable is usually documentation, not HSA.
Costs vary by product type, evaluation route, and whether you use external regulatory consultants. Key cost components include:
Contact Innorini for a tailored cost estimate based on your product and target timeline.
Missing GMP certificates, stability data, or quality agreements cause screening rejection and delays. Conduct a pre-submission gap analysis.
Misclassifying a therapeutic as a supplement (or vice versa) leads to rejection or enforcement action. Get a formal classification opinion.
Foreign companies cannot submit directly. Appoint a Singapore registrant before starting the dossier.
Taking months to respond to HSA queries extends the timeline. Have technical teams ready before submission.