Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

New drug application, verification evaluation (NDA-1, NDA-2, NDA-3 (verification route))

Singapore · Health Sciences Authority · New drugs

Reliance route, abridged reviewHigh confidenceLast verified October 3, 2026

Review target

60 working days

performance goal

Legal time limit

Not published

Steps

12 requirements

What is the New drug application, verification evaluation in Singapore?

A reliance route for a new medicine approved by at least two of the agency's six reference regulators: the FDA, the EMA (centralised procedure), Health Canada, the UK MHRA, Swissmedic and the TGA. The applicant sends the unredacted assessment reports of the primary reference agency, which must have approved the product within three years. The target is 50 working days for screening and 60 working days for evaluation. A new medicine with two qualifying reference approvals, identical quality, and no need for a local benefit-risk review.

How long does the New drug application, verification evaluation take?

The official review target is 60 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.

How much does the New drug application, verification evaluation cost?

The evaluation fee, nda-1 or nda-2, verification route is SGD 17,100 for Fee list updated 4 September 2026.

What are the steps of the New drug application, verification evaluation?

1. Online application and dossier; 2. Screening (50 days); 3. Screening questions (clock stopped); 4. Evaluation (60 days); 5. Evaluation questions (clock stopped); 6. Regulatory decision.

Does the New drug application, verification evaluation rely on other regulators?

Yes. It relies on approvals from Australia, Canada, Switzerland, European Union, United Kingdom, United States (verification, verification, verification, verification, verification, verification).

Outcome: Registration in the Register of Therapeutic Products. The registration is kept by paying a yearly retention fee.

Legal basis: Health Products Act 2007; Health Products (Therapeutic Products) Regulations 2016

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

About 110 days end to end with the official step targets, of which up to 20 days are clock stops (time the applicant uses to answer). Targets, not actual times.

Steps

In order, with the official target for each step

1. Online application and dossierThe applicant files online and sends the full dossier within 5 working days. The screening fee is charged at filing.
2. Screening50 working daysThe agency checks that the dossier is complete and that the application type and route are right. Target: 50 working days.
3. Screening questions (clock stopped)up to 20 days, clock stopped, only in some casesThe applicant has 20 working days to answer each question. At most two question rounds are sent during screening.
4. Evaluation60 working daysStarts on the date the application is accepted. The evaluation fee is charged at acceptance. Target: 60 working days to a decision, not counting the applicant's answer time.
5. Evaluation questions (clock stopped)clock stopped, only in some casesThe applicant answers the agency's questions. This time does not count toward the target.
6. Regulatory decisionThe outcome is approval, approvable (approval after minor issues are fixed), non-approvable, or rejection. An approved product enters the Register of Therapeutic Products.

Requirements

What the applicant must provide or meet

Local presence

Applicant is a local companyThe applicant must be a company registered in Singapore with the Accounting and Corporate Regulatory Authority. After approval, the applicant becomes the product registrant.

Other

Dossier format: ICH CTD or ASEAN CTDThe dossier follows either the ICH Common Technical Document or the ASEAN Common Technical Document format. The eCTD option is for the ICH format only.
Patent declarationThe applicant declares whether the product is covered by a patent in force that could block registration.

Language

Documents in EnglishAll documents are in English and sent in electronic form.

Clinical data

Reference agency assessment reportsUnredacted and unedited clinical and quality assessment reports from the chosen primary reference agency. Reports from the public domain are not accepted.

Nonclinical data

Reference agency assessment reportsNonclinical review is based on the reference agency's assessment.

Quality and manufacturing

Official time targets

Targets, not actual review times

Longest clock stopofficial guidance. Time allowed to answer each screening question.	20 working days
Validationperformance goal. Screening target. Time spent waiting for the applicant's answers is not counted.	50 working days
Review targetperformance goal. Evaluation target from acceptance to decision, without the applicant's answer time. These are official targets, not actual review times.	60 working days

Fees

Official amounts in the local currency

Fee	Amount
Evaluation fee, NDA-1 or NDA-2, verification routeApplication · Fee list updated 4 September 2026	SGD 17,100
Evaluation fee, NDA-3 (further strength), verification routeApplication · Fee list updated 4 September 2026	SGD 6,030
Screening fee, new drug application, verification routeApplication · Fee list updated 4 September 2026	SGD 610

Reliance on other regulators

AustraliaVerification, target 60 daysTherapeutic Goods Administration.
CanadaVerification, target 60 daysHealth Canada.
SwitzerlandVerification, target 60 daysSwissmedic.
European UnionVerification, target 60 daysEuropean Medicines Agency, centralised procedure only.
United KingdomVerification, target 60 daysUK MHRA, national procedure, or as reference member state in EU procedures on or before 31 January 2020.
United StatesVerification, target 60 daysUS Food and Drug Administration.

After approval

Report serious adverse reactions within 15 daysManufacturers, importers, suppliers and registrants report serious adverse reactions at once and no later than 15 days after they learn of them. Defects that are a serious threat to health are reported within 48 hours.
Periodic benefit-risk reports when requested(in some cases)The agency may ask for periodic benefit-risk evaluation reports for specific products through the registration conditions.

New drug application, verification evaluation (NDA-1, NDA-2, NDA-3 (verification route))

What is the New drug application, verification evaluation in Singapore?

How long does the New drug application, verification evaluation take?

How much does the New drug application, verification evaluation cost?

What are the steps of the New drug application, verification evaluation?

Does the New drug application, verification evaluation rely on other regulators?

How the pathway works

Timeline with clock stops

Steps

Requirements

Local presence

Other

Language

Clinical data

Nonclinical data

Quality and manufacturing

Official time targets

Fees

Reliance on other regulators

Inspection

After approval

Reference approval

Eligibility