How medicines and medical devices get approved in Singapore

For a new medicine that no drug regulatory agency in the world has approved yet. The agency reviews the full quality, nonclinical and clinical data. The applicant gives notice at least two months before filing. The target is 50 working days for screening and 270 working days for evaluation, without the applicant's answer time. Products with new safety and efficacy data get 5 years of data exclusivity.

Full application, new active substance · target 270 days · verified October 3, 2026

For a new medicine already approved by at least one drug regulatory agency. The agency reviews full quality data but only overviews and pivotal reports for the clinical part. Quality and directions for use must match the approval. The target is 50 working days for screening and 180 working days for evaluation, without the applicant's answer time.

Reliance route, abridged review · target 180 days · verified October 3, 2026

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.

Reliance route, abridged review · target 60 days · relies on AU, CA, CH, EU, GB, US · verified October 3, 2026

Used when the active ingredient is already registered in Singapore but the product is new: a new combination, dosage form, presentation, formulation, route, indication, dose or patient group. The applicant then picks the full, abridged or verification route, which sets the data needed, the fee and the target time. Further strengths are filed as NDA-3.

Full or mixed application, known active substance · target 180 days · verified October 3, 2026

An applicant on the abridged route can ask for priority review of a life-saving drug for a serious, life-threatening condition with unmet need in Singapore. Cancer and infectious diseases such as dengue, tuberculosis, hepatitis and malaria get primary consideration. The agency says at acceptance whether priority review is granted. It has not published a separate target time.

Priority or accelerated review · verified October 3, 2026

A framework led by the US FDA for joint review of cancer medicines with partner agencies, including Singapore. The FDA selects products with the US applicant. Filing in Singapore follows the normal registration rules, fees and target times, but agencies share their reviews. Each agency makes its own decision.

Work-sharing or joint review · relies on US · verified October 3, 2026

Singapore is a member of the Access Consortium with Australia, Canada, Switzerland and the United Kingdom. Work-sharing initiatives cover new active substances, generics and biosimilars filed with at least two member agencies. The agencies share the assessment work, and each agency issues its own decision.

Work-sharing or joint review · relies on AU, CA, CH, GB · verified October 3, 2026

Licensed hospitals, clinics and nursing homes can ask the agency to approve import of an unregistered medicine for a specific patient. It is meant for life-saving therapy when no effective registered option exists. Each consignment needs approval, holds up to three months of supply per patient, and is valid for 6 months. The target is 14 working days and there is no fee. The agency does not assess the product.

Early or compassionate access · target 14 days · verified October 3, 2026

Biosimilars are filed as new drug applications (NDA-2, with NDA-3 for further strengths), not as generics. The product must be similar to a biologic registered in Singapore and approved by at least one reference agency. Only the abridged route (target 180 working days) and the verification route (target 60 working days) are open. Vaccines and plasma-derived products cannot use this pathway.

Biosimilar application · target 180 days · relies on AU, CA, CH, EU, GB, US · verified October 3, 2026

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.

Generic application · target 240 days · verified October 3, 2026

A reliance route for a chemical generic approved by at least one of the agency's six reference regulators within the last two years. Quality must be identical to that approval, and the applicant sends the reference agency's unredacted assessment reports. The target is 50 working days for screening and 120 working days for evaluation.

Generic application · target 120 days · relies on AU, CA, CH, EU, GB, US · verified October 3, 2026

A verification route for chemical generics manufactured in India. It has the same eligibility rules as the generic verification route. The first answer to the applicant during screening has a target of 14 working days, and evaluation has a target of 90 working days, without the applicant's answer time.

Generic application · target 90 days · relies on AU, CA, CH, EU, GB, US · verified October 3, 2026

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.

Generic application · verified October 3, 2026

A pilot in which the agency and Malaysia's National Pharmaceutical Regulatory Agency jointly assess a generic medicine filed in both countries. The pilot is looking for an immediate-release oral solid generic supported by bioequivalence data.

Work-sharing or joint review · relies on MY · verified October 3, 2026

Singapore has three access classes: prescription-only, pharmacy-only and general sale list. A non-prescription product is filed as an abridged new drug application. If the active substance is not prescription-only in Singapore and the product is sold without prescription in Australia, Canada, the United States or the United Kingdom, the applicant can ask to skip clinical and nonclinical data and rely on standard reference texts. The agency decides the final access class.

Non-prescription application · target 180 days · relies on AU, CA, GB, US · verified October 3, 2026

A registered medicine can move to a lower access class, for example from prescription-only to pharmacy-only, or from pharmacy-only to general sale. The registrant files a major variation (MAV-2) on the abridged route. There are no screening or evaluation fees. Targets are 50 working days for screening and 180 working days for evaluation.

Non-prescription application · target 180 days · verified October 3, 2026

Higher-risk cell, tissue and gene therapy products (Class 2) need registration. This route is for a product not yet approved by any of the agency's comparable overseas regulators. The applicant gives notice two months before filing. Targets are 50 working days for screening and 270 working days for evaluation, without the applicant's answer time.

Full application, new active substance · target 270 days · verified October 3, 2026

For a Class 2 cell, tissue or gene therapy product already approved by at least one comparable overseas regulator: the TGA, Health Canada, the FDA, the EMA or the UK MHRA. Targets are 50 working days for screening and 180 working days for evaluation, without the applicant's answer time.

Reliance route, abridged review · target 180 days · relies on AU, CA, EU, GB, US · verified October 3, 2026

Lower-risk (Class 1) cell and tissue products do not need registration. The supplier files a product notification and must receive the agency's written acceptance before supply. The outcome is expected within 14 working days and the fee is 95 Singapore dollars.

Other route · target 14 days · verified October 3, 2026

A device that contains a medicine in a supporting role, such as a drug-eluting stent, is regulated as a device when its main action is physical. Such devices are always Class D and are reviewed jointly by the device and medicines teams. The abridged route (target 220 working days) needs a reference device approval and approval of the drug part by a competent drug regulator. Otherwise the full route applies (target 310 working days).

Device: registration or licence with the regulator · verified October 3, 2026

Low-risk (Class A) devices, including Class A IVDs and software, do not need product registration. Manufacturers and importers list them through a product notification, and the devices must still meet the essential principles for safety and performance. Dealer licensing, adverse event reporting and other duties still apply.

Device: premarket notification · verified October 3, 2026

For a moderately low-risk (Class B) device with no approval from any of the agency's reference regulators. The agency reviews a full ASEAN CSDT dossier, including full preclinical reports and a clinical evaluation report. The target is 160 working days from receipt of the application, without stop-clock time.

Device: registration or licence with the regulator · target 160 days · verified October 3, 2026

For a Class B device approved for the same labeled use by at least one of the agency's reference regulators, or registered in Malaysia under the reliance program. The target is 100 working days from receipt of the application, without stop-clock time.

Reliance route, abridged review · target 100 days · relies on AU, CA, EU, JP, MY, US · verified October 3, 2026

A Class B device is listed on the register as soon as the application is filed and paid, if it has strong reference approvals and a clean safety record. Either one independent reference approval with three years of marketing there, or two independent reference approvals, is needed. Standalone medical mobile apps need one approval. The agency checks the documents after listing and cancels the registration without refund if the device did not qualify.

Reliance route, recognition or verification · target 0 days · relies on AU, CA, EU, JP, US · verified October 3, 2026

For a moderately high-risk (Class C) device with no approval from any of the agency's reference regulators. The agency reviews a full ASEAN CSDT dossier with full preclinical reports and a clinical evaluation report. The target is 220 working days from receipt of the application, without stop-clock time.

Device: registration or licence with the regulator · target 220 days · verified October 3, 2026

For a Class C device approved for the same labeled use by at least one of the agency's reference regulators, or registered in Malaysia under the reliance program. The target is 160 working days from receipt of the application, without stop-clock time.

Reliance route, abridged review · target 160 days · relies on AU, CA, EU, JP, MY, US · verified October 3, 2026

A faster reliance route for Class C devices. ECR-1 needs one independent reference approval, three years of marketing there and a clean safety record. ECR-2 needs two independent reference approvals. Non-bioactive hip, knee and shoulder joint replacements are excluded. The target is 120 working days from receipt of the application, without stop-clock time.

Reliance route, abridged review · target 120 days · relies on AU, CA, EU, JP, US · verified October 3, 2026

For a high-risk (Class D) device with no approval from any of the agency's reference regulators. The agency reviews a full ASEAN CSDT dossier with full preclinical reports and a clinical evaluation report. The target is 310 working days from receipt of the application, without stop-clock time.

Device: registration or licence with the regulator · target 310 days · verified October 3, 2026

For a Class D device approved for the same labeled use by at least one of the agency's reference regulators, or registered in Malaysia under the reliance program. Devices excluded from the expedited route, such as active implants, use this route or the full route. The target is 220 working days from receipt of the application, without stop-clock time.

Reliance route, abridged review · target 220 days · relies on AU, CA, EU, JP, MY, US · verified October 3, 2026

A faster reliance route for Class D devices with approvals from at least two independent reference regulators for the same labeled use. Active implants, some other implants, joint replacements, devices with a registrable drug and high-risk IVDs for HIV or donor testing are excluded. The target is 180 working days from receipt of the application, without stop-clock time.

Reliance route, abridged review · target 180 days · relies on AU, CA, EU, JP, US · verified October 3, 2026

An opt-in scheme for Class B, C and D devices on the full route. Review targets are 35 percent shorter than the standard full route: 104 working days for Class B, 143 for Class C and 202 for Class D. Route 1 is for devices in six focus areas that meet an unmet clinical need. Route 2 is open to other full-route devices at a higher fee. Devices with a registrable medicinal product are excluded.

Priority or accelerated review · verified October 3, 2026

A standalone medical mobile app in Class C can be listed on the register immediately after filing and payment if it has one independent reference approval for the same use and a clean safety record. The agency checks the documents after listing.

Reliance route, recognition or verification · target 0 days · relies on AU, CA, EU, JP, US · verified October 3, 2026