Regulatory strategy session
We review your product, target market, and existing documentation to define the optimal regulatory pathway.
Full-spectrum regulatory support for pharmaceutical products in Singapore, from registration to post-market compliance.
INNORINI PTE. LTD. (UEN 202015523Z) provides HSA regulatory affairs services in Singapore for overseas and local pharmaceutical companies. Our services include therapeutic product registration, variations and renewals, Special Access Route (SAR) applications, label and artwork compliance review, import and wholesale licence management, and post-market pharmacovigilance support. We act as the local regulatory partner for companies without a Singapore office.
At a glance
| Service | Description |
|---|---|
| Product registration | CTD dossier preparation, gap analysis, HSA submission, query management |
| Variations | Post-approval changes to formulation, manufacturing site, labelling, or specifications |
| Renewals | Product licence renewal submissions and documentation |
| Special Access Route (SAR) | Applications for unregistered therapeutic products for named patients |
| Label compliance | Review of product labels and artwork against HSA requirements |
| Licence management | Importer's and wholesaler's licence applications and renewals |
| Post-market support | Adverse event reporting, field safety notices, regulatory correspondence |
| Health supplement notification | Voluntary notification of health supplements under HSA framework |
In Singapore, product registration and company licensing are two separate requirements:
Innorini holds an Importer's Licence and can assist with wholesaler's licence applications. We can also act as the local product registrant for overseas manufacturers.
Product classification determines the registration pathway, documentation requirements, and permitted channels of supply. Understanding the correct classification is the first step in any regulatory strategy.
| Classification | Key Requirements |
|---|---|
| Prescription-Only Medicine (POM) | Full CTD dossier, doctor's prescription required, HSA marketing authorisation |
| Pharmacy-Only Medicine (P) | Supplied under pharmacist supervision, no prescription required |
| General Sale List (GSL) | Safe for self-selection, available through general retail |
| Over-the-Counter (OTC) | Non-prescription status must be supported by reference agency documentation |
| Biologicals / Biosimilars | ICH comparability frameworks, stepwise non-clinical and clinical evaluation |
| Controlled Drugs | Misuse of Drugs Act requirements, special licences and inventory controls |
| Health Supplements | Voluntary notification scheme, not product licensing; must comply with ingredient and claim restrictions |
| Chinese Proprietary Medicines (CPM) | Separate listing requirements under CPM guidelines, local clinical use evidence |
HSA was one of the first three regulators worldwide to be designated a WHO-Listed Authority for medicines (October 2023). The HSA regulatory framework is internationally harmonised with ICH, PIC/S, and ASEAN guidelines, making Singapore a recognised reference agency for regional registrations.
Key advantages of Singapore as a regulatory hub:
Innorini helps overseas manufacturers navigate this framework by acting as the local registrant, licence holder, and regulatory partner.
The Special Access Route allows unregistered therapeutic products to be imported and supplied in Singapore for named patients where no suitable registered alternative is available. SAR applications can be made by licensed hospitals, retail pharmacies, or by a company acting on behalf of a clinic (requiring both importer and wholesaler licences).
Innorini can support SAR applications for clinics and healthcare institutions. Learn more on our Special Access Route Singapore page.
We review your product, target market, and existing documentation to define the optimal regulatory pathway.
We identify what documentation exists, what is missing, and what needs to be prepared for HSA submission.
We compile the CTD dossier, ensure compliance with HSA requirements, and submit through the PRISM system.
We handle all HSA queries during evaluation, coordinating with your technical teams until approval.
We finalise import/wholesale licences, label compliance, and support the first commercial shipment.
We manage variations, renewals, adverse event reporting, and regulatory updates for the product lifecycle.