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

Standard essential medicine application (GDA (standard essential medicine))

Singapore · Health Sciences Authority · Generics

Generic applicationHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

12 requirements

Application fee

What is the Standard essential medicine application in Singapore?

A generic drug application path, in effect since 16 January 2026, for unregistered chemical medicines with long local clinical use that have no Singapore reference product. The product must be on the national Standard Drug List or on a public hospital formulary for at least 5 years. An expression of interest is needed at least 3 months before filing. An older essential medicine used for years in Singapore hospitals that has never been registered and has no registered reference product.

What are the steps of the Standard essential medicine application?

1. Expression of interest; 2. Online application and dossier; 3. Screening (50 days); 4. Screening questions (clock stopped); 5. Evaluation; 6. Evaluation questions (clock stopped); 7. 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 70 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. Expression of interestSent at least 3 months before the planned filing. The agency confirms in writing whether the product can use this pathway.
2. Online application and dossierThe applicant files online and sends the full dossier within 5 working days. The screening fee is charged at filing.
3. Screening50 working daysThe agency checks that the dossier is complete and that the application type and route are right. Target: 50 working days.
4. 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.
5. EvaluationEvaluated as a generic drug application. The agency has not published a separate target for this pathway.
6. Evaluation questions (clock stopped)clock stopped, only in some casesThe applicant answers the agency's questions. This time does not count toward the target.
7. Regulatory decision

Official time targets

Targets, not actual review times

Validationperformance goal. Screening target for generic drug applications. Official target, not actual time.

50 working days

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Rule changes

New pathway for standard essential medicinesIn force, January 16, 2026, effective January 16, 2026

Other routes in Singapore: New drug application, full evaluation, New drug application, abridged evaluation, New drug application, verification evaluation, New drug application for a registered active ingredient (NDA-2), Generic drug application, abridged evaluation, Generic drug application, verification evaluation, Generic drug application, verification-CECA evaluation, Priority review, Project Orbis (cancer medicines), Access Consortium work sharing, Singapore-Malaysia generic work-sharing pilot, Special access for an unregistered medicine (named patient). See all routes on the Singapore page or explore them in the .

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.

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.
Expression of interest firstAn expression of interest goes to the agency at least 3 months before the planned filing. Filing follows only after written acceptance.

Language

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

Clinical data

Long local clinical use instead of new trialsThe indication must be well documented in standard references. Long local clinical use serves as evidence of safety and efficacy.

Nonclinical data

No nonclinical data(optional)Nonclinical data are generally not needed for a generic drug application.

Quality and manufacturing

Pharmacopoeia qualityQuality meets recognized pharmacopoeia monographs, with extra support such as 5 years of marketing in a reference country or bioequivalence data where only minimum monographs exist.

Inspection

GMP check of new overseas makers(in some cases)New overseas manufacturing sites go through a Good Manufacturing Practice conformity assessment by the agency.

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.

Eligibility

On a national or hospital medicines listOn the Ministry of Health Standard Drug List, or on a public hospital Pharmacy and Therapeutics list for at least 5 years. No Singapore reference product exists.