ACE-HSA Priority Track

ELIGIBILITY AND SELECTION

1.    What health technologies are currently covered by the Priority Track, and will the scope change over time? 

The Priority Track currently applies to where ACE-HSA concurrent review processes are more mature such as therapeutic drugs and Cell, Tissue and Gene Therapy Products (CTGTPs). The scope of the Priority Track may be reviewed over time, taking into account implementation experience and evolving needs.

2.    What are the selection criteria for the Priority Track?

Priority will be given to products that demonstrate significant innovation that addresses unmet clinical needs, meet HTA evidential standards for cost-effectiveness and deliver strong value to the healthcare system, align with Singapore's health or disease priorities¹, and show clear intent to commercialise in Singapore. Additional consideration may be given to companies or products that can generate clear economic value-add for Singapore².

¹ Examples include diabetes, ischaemic heart diseases, musculoskeletal conditions and priority areas under MOH/NMRC’s Research, Innovation and Enterprise 2030 (RIE2030) Strategy and Priorities ↗ (opens in new tab).

² Examples include conducting in-house R&D or co-development or research partnership, clinical trials, in-house manufacturing, local Contract Research Organisation (CRO) or Contract Development and Manufacturing Organisation (CDMO) partnerships, or supplier development

3.    How many products will be selected each year?

The number selected each year will depend on the pipeline of suitable products identified through the annual pipeline scanning process and whether they meet the Priority Track’s selection and evidentiary requirements.

HOW COMPANIES CAN PARTICIPATE

4.    How and when can companies participate?

Companies should continue to share information on their pipeline products through ACE's existing annual pipeline scanning process. This includes products expected to receive HSA approval within the next two to three years. For 2026, this will be conducted in November/December, and subsequently in September/October each year from 2027 onwards. If you wish to be notified when the pipeline scanning exercise commences, you may write to ace@moh.gov.sg.   

Companies whose products are selected for the Priority Track will subsequently be contacted (from around August in the following year) and invited to participate by submitting their products for concurrent regulatory review by HSA (if they have not already done so) and HTA evaluation through ACE’s Company-Led Submission (CLS) process.

No separate application for the Priority Track is required.

5.    What if I missed the deadline for ACE's annual pipeline scanning exercise?

Products are generally prioritised together in the same exercise to ensure a fair and consistent approach across products. As such, companies should closely adhere to the stated timelines to be considered for the ACE-HSA Priority Track. Those who miss the deadline  may still submit their product information to ACE. However, whether the product can be considered in the same round of prioritisation and selection will be assessed on a case-by-case basis.

6.    What happens after my product is selected?

If your product is selected, ACE will contact you to invite you to participate in the Priority Track and advise on the next steps (e.g. pre-submission advice).

For selected products, ACE and HSA will closely coordinate evaluation timelines and stakeholder engagement so that, where applicable, HTA evaluation can proceed concurrently with regulatory evaluation. This aims to shorten the time between regulatory approval and the first HTA decision.

7.    What happens if my product is not selected?

For products eligible to be considered under ACE’s CLS Process, companies may proceed with surfacing their products for HTA evaluation during regular CLS windows ↗ (opens in new tab).

Companies are still welcome to proceed with their regulatory submissions to HSA through the regular channels, to register their therapeutic products or CTGTPs for use in Singapore.

WHAT PARTICIPATION IN THE PRIORITY TRACK MEANS 

8.    Does selection guarantee regulatory approval and/or a positive HTA outcome or government reimbursement?

ACE and HSA will continue to apply existing evidentiary and assessment requirements for safety, clinical- and cost-effectiveness. Participation in the Priority Track does not guarantee the outcome of regulatory or funding decisions.

Products that do not meet existing regulatory, clinical effectiveness or cost-effectiveness requirements will not receive favourable decisions solely because they participate in the Priority Track

9.    Should companies wait for the Priority Track invitation before submitting to HSA?

No. Companies can continue with their planned regulatory submissions to HSA through the regular channels while awaiting the outcome of the selection process. These submissions will continue to be processed according to existing timelines.

FEES AND TIMELINES

10. Are there any costs associated with participating in the Priority Track?

There is no fee for submitting pipeline information to ACE as part of the annual pipeline scanning and prioritisation process.

Standard HSA product registration fees and ACE's CLS fees will continue to apply for products where the respective regulatory and HTA evaluations are undertaken.

11. Is the six-to-nine-month timeframe guaranteed?

The six-to-nine-month timeframe is a target for the time between regulatory approval and the first HTA decision. This applies only to products going through ACE's CLS process under the Priority Track, subject to companies’ timely submission of complete and necessary information required for evaluations to proceed.