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

Generic drug application, abridged evaluation (GDA-1, GDA-2 (abridged route))

Singapore · Health Sciences Authority · Generics

Generic applicationHigh confidenceLast verified October 3, 2026

Review target

240 working days

performance goal

Legal time limit

Not published

Steps

12 requirements

What is the Generic drug application, abridged evaluation in Singapore?

For a chemical generic that is essentially the same as a registered Singapore reference product and already approved by at least one drug regulatory agency. The applicant shows bioequivalence instead of new clinical data. The target is 50 working days for screening and 240 working days for evaluation, without the applicant's answer time. A chemical generic with at least one foreign approval that does not meet the verification criteria.

How long does the Generic drug application, abridged evaluation take?

The official review target is 240 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 Generic drug application, abridged evaluation cost?

The evaluation fee, gda-1 (first strength), abridged route is SGD 4,280 for Fee list updated 4 September 2026.

What are the steps of the Generic drug application, abridged evaluation?

1. Online application and dossier; 2. Screening (50 days); 3. Screening questions (clock stopped); 4. Evaluation (240 days); 5. Evaluation questions (clock stopped); 6. Regulatory decision.

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 290 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. Evaluation240 working daysStarts on the date the application is accepted. The evaluation fee is charged at acceptance. Target: 240 working days to a decision, not counting the applicant's answer time. The first set of questions is due by about working day 150.
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

No new clinical efficacy dataClinical and animal data are generally not needed. The applicant shows interchangeability with the Singapore reference product, for example with bioequivalence and comparative dissolution studies.

Nonclinical data

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
First review cycleperformance goal. Working days from acceptance to the first set of evaluation questions.	150 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.	240 working days

Fees

Official amounts in the local currency

Fee	Amount
Evaluation fee, GDA-1 (first strength), abridged routeApplication · Fee list updated 4 September 2026	SGD 4,280
Evaluation fee, GDA-2 (further strength), abridged routeApplication · Fee list updated 4 September 2026	SGD 2,450
Screening fee, generic drug application, abridged routeApplication · Fee list updated 4 September 2026	SGD 610

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.

Generic drug application, abridged evaluation (GDA-1, GDA-2 (abridged route))

What is the Generic drug application, abridged evaluation in Singapore?

How long does the Generic drug application, abridged evaluation take?

How much does the Generic drug application, abridged evaluation cost?

What are the steps of the Generic drug application, abridged evaluation?

How the pathway works

Timeline with clock stops

Steps

Requirements

Local presence

Other

Language

Clinical data

Nonclinical data

Official time targets

Fees

Quality and manufacturing

Inspection

After approval

Eligibility

Reference approval