The Health Sciences Authority (HSA) is Singapore’s national regulator for health products, including the country’s clinical trial framework. Any interventional trial conducted in Singapore — whether testing a conventional drug, a biologic, a cell/tissue/gene therapy product, or an unregistered use of a marketed medicine — needs pre-trial clearance from HSA, in addition to ethics review from an Institutional Review Board (IRB). Unlike a single-track system such as the FDA’s IND pathway, HSA actually runs three distinct application types — the Clinical Trial Authorisation (CTA), the Clinical Trial Notification (CTN), and the Clinical Trial Certificate (CTC) — and which one applies depends on what kind of product is being tested and its local registration status, not on trial phase alone. This guide explains what triggers each pathway, how they differ in review depth and timeline, and how HSA’s process compares to neighbouring-region frameworks research administrators are likely to encounter in the same multi-country submission.
Why Singapore has three pathways, not one
The split traces back to Singapore’s underlying product legislation, which currently runs on two parallel legal tracks. Most conventional pharmaceuticals and biologics are regulated as therapeutic products under the Health Products Act (HPA) and its Health Products (Therapeutic Products) Regulations 2016 — this is the newer, harmonised framework Singapore has been migrating products into. A remaining category, including things like Chinese Proprietary Medicines and health supplements being studied for disease treatment or prevention, is still regulated as a medicinal product under the older Medicines Act. HSA uses a different application for each track:
- Therapeutic products (and Class 2 cell, tissue, and gene therapy products, or CTGTPs) go through a CTA or CTN, depending on registration/label status.
- Medicinal products go through a CTC, regardless of phase.
All three applications are submitted electronically through PRISM (Pharmaceutical Regulatory Information System), HSA’s online licensing portal, which requires a CRIS account plus Corppass (for organisations) or an HSA PIN. There are no application fees for any of the three pathways.
Clinical Trial Authorisation (CTA)
A CTA is HSA’s full-review pathway for a therapeutic product or Class 2 CTGTP that is not yet locally registered, or for an unapproved use of a product that is already registered — a new indication, a new patient population, a new route of administration, or a new dosing regimen. It also applies to healthy-volunteer studies unless the product is already approved for that population. Because the product (or the proposed use) has no existing local safety/efficacy track record with HSA, the application requires the fuller evidentiary package: investigator’s brochure, GMP documentation, manufacturing and quality data, and nonclinical/clinical data supporting the proposed use.
Standard CTA review is 30 working days. Two variations sit either side of that: Phase 1 bioavailability/bioequivalence studies get an expedited 15 working days, while trials of CTGTPs (reflecting their higher intrinsic risk) take up to 60 working days. A CTA submission may run in parallel with the IRB ethics review — sponsors don’t have to wait for IRB approval before filing with HSA.
Clinical Trial Notification (CTN)
A CTN is the lighter-touch counterpart to the CTA, available when the trial involves only therapeutic products or Class 2 CTGTPs that are already locally registered and are being used strictly within their approved local label (approved indication, population, route, and dosing). Because HSA has already assessed the product’s quality, safety, and efficacy through the registration process, a CTN undergoes a simplified screening and verification check rather than a full technical review.
That difference shows up directly in timeline: HSA’s target is 5 working days for a CTN, versus 30 for a standard CTA. The trade-off is sequencing: a CTN submission should only be made after the trial has already received IRB approval, unlike the CTA’s parallel-track option.
Clinical Trial Certificate (CTC)
A CTC is required before initiating any clinical trial of a medicinal product — the Medicines Act track described above — investigating one or more products for the treatment or prevention of disease. HSA’s stated standard timeline for a CTC decision is 30 working days (excluding any time the sponsor spends responding to HSA queries), regardless of the product’s prior registration status; the application differs by registered vs. unregistered product mainly in supporting documentation (an approved product label for a registered product; an investigator’s brochure for an unregistered one).
A related notification — the Clinical Research Material (CRM) notification — can be filed in the same submission as a CTC application when the trial requires importing investigational or comparator material. HSA sends an acknowledgement for the CRM notification immediately on submission, which lets the sponsor’s importer begin moving supply into Singapore ahead of the full CTC decision.
Which pathway applies: the decision logic
| Question | Answer determines |
|---|---|
| Is the investigational product a therapeutic product (or Class 2 CTGTP) under the Health Products Act, or a medicinal product under the Medicines Act? | Medicinal product → CTC, always. Therapeutic product/CTGTP → go to next question. |
| Is the therapeutic product/CTGTP already locally registered in Singapore? | No, or registered but proposed for an unapproved use → CTA. Yes, used strictly per approved label → CTN. |
| Is it a Phase 1 bioavailability/bioequivalence study of a CTA-track product? | 15 working days instead of the standard 30. |
| Is it a CTGTP trial? | Up to 60 working days, reflecting the higher-risk category. |
In practice, most first-in-Singapore trials of a novel investigational drug or a cell/gene therapy will be CTAs; most Phase 4 or post-registration comparative-effectiveness studies of an already-marketed, on-label product will be CTNs; and trials of Chinese Proprietary Medicines or supplements studied for a disease indication will be CTCs. Sponsors running a multi-country program should confirm pathway classification early with HSA’s published guidance rather than assume the trial phase alone determines the route, since product/registration status — not phase — is the actual trigger.
A note on terminology: two different “CTAs”
Research administrators working across jurisdictions should be careful not to confuse HSA’s Clinical Trial Authorisation with the unrelated, much more common use of the initialism CTA in US/UK trial operations to mean a Clinical Trial Agreement — the contract between sponsor and site. The two share an abbreviation but refer to entirely different documents in entirely different regulatory contexts; Singapore’s usage is a regulatory authorisation from HSA, not a bilateral contract.
IRB review and the overall submission sequence
HSA’s clearance is necessary but not sufficient: every trial also needs ethics approval from a Singapore-registered IRB before it can start. The two review tracks interact differently depending on pathway — a CTA can be filed with HSA while IRB review is still underway, but a CTN can only be submitted once IRB approval is already in hand, since the CTN’s simplified screening assumes ethics review has already vetted the trial. Sponsors coordinating both timelines in parallel should build their internal Gantt chart around whichever review is on the critical path for the chosen pathway, rather than assuming the two always run concurrently.
How HSA compares to neighbouring frameworks
For sponsors running the same protocol across Asia-Pacific sites, HSA’s tiered CTA/CTN/CTC structure is a useful point of comparison against other regional authorities CASRAI covers: South Korea’s MFDS IND-equivalent pathway, China’s NMPA clinical trial approval process, and India’s CDSCO approval pathway. Outside the region, the same underlying question — does the regulator run one track or several, and what determines routing — comes up again in CASRAI’s guides to South Africa’s SAHPRA process, Mexico’s COFEPRIS pathway, Brazil’s ANVISA process, Switzerland’s Swissmedic/ClinO framework, and the UK’s 2026 Clinical Trials Regulations reform. All of these sit alongside the common baseline expectation of Good Clinical Practice (GCP) conduct standards, harmonised internationally through ICH.
Frequently asked questions
Do I need HSA clearance for an investigator-initiated trial, or only for sponsor-led industry trials?
HSA’s CTA/CTN/CTC requirement applies to interventional clinical trials of the covered product categories regardless of who initiates them — a locally-registered sponsor is required for the application either way, which for an investigator-initiated trial is typically the institution rather than a commercial company.
How long does the whole process take, sponsor submission to first patient in?
The HSA review itself ranges from 5 working days (CTN) to 60 working days (CTGTP-track CTA), but the realistic end-to-end timeline also depends on IRB review, site contracting, and any HSA clarification requests, which pause the regulatory clock. Building in additional time beyond the headline HSA figure is standard practice.
Can a trial change pathway partway through, e.g. from CTA to CTN?
If a product’s local registration status changes during a long-running program (for example, it becomes locally registered mid-study for a use the trial already covers), a subsequent related application for the same product could potentially move to the CTN track; sponsors should confirm this directly with HSA rather than assume it, since it depends on the specific facts of the registration and the trial’s approved scope.
Is there a fee for CTA, CTN, or CTC applications?
No. HSA states there are no fees involved in clinical trial applications submitted through PRISM.
This guide reflects HSA’s published clinical trial application guidance as of 2026. Regulatory processes and timelines are periodically updated — sponsors should confirm current requirements directly against HSA’s own clinical trials pages before filing.
