Medicines
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1. Why us?
The Health Sciences Authority (HSA) is the regulatory body responsible for evaluating and approving medical devices in Singapore to ensure their safety, quality, and effectiveness before they are marketed.
Registering your medicine is a legal requirement for importation, distribution, and sale in Singapore. It ensures that your product has undergone rigorous evaluation based on national standards, thereby building trust with healthcare providers and end-users.
As a dedicated regulatory consulting firm, we hope to guide you through every step of the registration process — from determining the classification, selecting the appropriate evaluation route, to compiling submission dossiers and liaising with the HSA. Our expertise ensures smoother market entry, so you can focus on innovation and business growth.
2.What is a Therapeutic Product?
In Singapore, our daily medicines are referred to as “Therapeutic Product” to differentiate it from Active Pharmaceutical Ingredients (APIs) and other forms of medicines. Therapeutic product is specifically talking about finished products, one that is ready to be taken by a patient directly. This article focuses on Chemical Medicines, as biologics will be discussed separately under “Biologics”
There are three different classifications of medicines in Singapore. General Sales List (GSL) is commonly known as ‘Over the Counter’ OTC medicines which patients have access to directly via retail pharmacies. ‘Pharmacy-Only’ (P) Medicines are also available over the counter, however, it can only be done under the supervision of a Pharmacist and kept behind locked cabinets. Prescription-Only Medicines (POM) are only available with a doctor's prescription.
3. How to register in Singapore?
A local company must be appointed to be your registrant. This can be a regulatory consulting company like us, or it can be done by your appointed distributor company/logistics company if they have the capability to do so.
4. What are the must-have requirements?
Dossier requirements:
HSA accepts ICH CTD dossier, or the Asean Common Technical Dossier (ACTD) which you can use for all SEA countries.
Patent:
Singapore is a country that respects international patent laws. We can help you to engage third party law firms to clear all patent issues (if any) before registration. For first-in-market generics, we can begin to submit within 18 months of Proprietary's patent expiration date.
GMP:
As of October 2024, Drug Substance Manufacturers must have GMP certificate as well, together with the requirement for Drug Product Manufacturers. Singapore is a PIC/S member, and recognizes GMP evaluation reports and certificates from other PIC/S members. Singapore also performs GMP assessment for overseas manufacturers, however this is currently on hold.
5. How is the process like in Singapore?
Singapore has a transparent process with clear stages of evaluation and official turn-around time which is closely fulfilled. There will an initial 50 working days of document screening which is not refundable to ensure all pertinent documents are in place before the dossier is accepted for evaluation. Usually, registrants opt for progressive payment, where deduction will only occur after the milestone has been reached.
| Evaluation stages | Description | Progressive Payment % |
|---|---|---|
| Stage 1: Acceptance for evaluation | The application has entered the evaluation queue. This marks the start of the evaluation timeline | 30% |
| Stage 2: Active evaluation in progress | Applicants can expect to receive the first set of evaluation queries (if any) from us towards the end of this stage.* | 40% |
| Stage 3: Evaluation at midway | Applicants are expected to submit the response to evaluation queries. | 20% |
| Stage 4: Completed evaluation |
Evaluation is completed. Application is now undergoing the regulatory decision phase, after which a regulatory decision# will be issued.
Applicants can still expect further queries from HSA during this stage. |
10% |
6. Renewal and Transfer of registrations
Singapore has no sunset policy. A registration can continue to remain registered despite not being marketed. Every year, a renewal fee will be deducted. As a regulatory consulting company that focuses on your registration needs, we can transfer the registration easily to your appointed distributor company if you desire, or when you decide to start up a company in Singapore on your own.
This is the leverage we can provide for you. By keeping product registrations independently managed through our company, brand owners retain full control over their regulatory assets. This allows you to negotiate commercial partnerships freely, switch distributors without regulatory disruption, and protect long-term market strategy without compliance issues or operational setbacks.
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