• Regulatory overview of cell, tissue or gene therapy product
• Guidance documents for CTGTP
• Fees and turnaround time for CTGTP
• Retain, cancel or transfer CTGTP registrations

• Controlled drugs and psychotropic substances
• Certificate of Pharmaceutical Product (CPP)
• Free Sale Certificate (FSC)
• Statement of Licensing Status (SLS)

Regulatory overview and requirements:

• Controlled drugs and psychotropic substances
• Certificate of Pharmaceutical Product (CPP) and Statement of Licensing Status (SLS)

Reprinting or reissuance of original hardcopy licences/certificates

Please ensure that all details entered are correct and accurate in your applications for licences/certificates before submitting them to us.

Note: We will only issue the original hardcopy for the following licences/certificates once. There will be no reprinting or reissuance. If you need another original document, please submit a new application in PRISM.

• Certificate of Pharmaceutical Product (CPP),
• Free Sale Certificate (FSC),
• Statement of Licensing Status (SLS),
• Licence to Import Controlled Drugs
• Licence to Export Controlled Drugs
• Approval to Import Therapeutic Products Containing Psychotropic Substances
• Approval to Export Therapeutic Products Containing Psychotropic Substances
• Import Authorisation for Psychotropic Substances
• Export Licence for Psychotropic Substances
• Certificate of Approval for Import of a Therapeutic Product
• Import Authorisation for Restricted Substances

Regulatory overview and requirements (For industry):

• Chinese Proprietary Medicines
• Health Supplements
• Homeopathic Medicines
• Medicated oils and balms
• Traditional Medicines

Product Classification:

Use our Complementary Health Products (CHP) Classification Tool for the classification of products such as Chinese Proprietary Medicines, Traditional Medicines, Health Supplements, Homeopathic Medicines etc.

Products used on animals, as well as products presented in the form of food and beverages, such as biscuits, cookies, coffee, and juice are not CHPs.

Useful links:

• Singapore Food Agency (SFA) for regulation of food products and supplements of food nature
• Food-Health Product Classification Tree to guide classification of food or health products
• Animal & Veterinary Service (AVS) for regulation of products used on animals

Bringing Complementary Health Products (CHPs) for personal use into Singapore

Clinical Trial Regulatory Submission

• HSA Guidance on determination of whether a clinical trial requires Clinical trial Authorisation (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC).
• HSA Guidance on regulatory requirements for new applications and subsequent submissions.

Clinical Research Materials Notification (CRM-N)

• Determine if you need a CRM-N   
• Submit a CRM-N

Participating in Clinical Trials (CT Register)

• Understand the possible benefits, risks and your rights in a clinical trial.
• Search for a clinical trial that you may be eligible for and contact the healthcare institution for more information.

• Regulatory overview of cosmetic products
• Use our Cosmetic Products Classification Guide to help you check whether your product is considered a cosmetic product in Singapore.
• Step-by-step guide on submitting a new cosmetic product notification or re-notification.

• Dealers’ Licensing and Certification
• Retail pharmacies licensing

 Licensing requirements and applications

• Therapeutic Products (TP)
• Chinese Proprietary Medicines (CPM)
• Cell, Tissue and Gene Therapy Products (CTGTP)
• Poisons (Form A Poisons Licence)
• Retail Pharmacy Licensing

Check

• Eligibility, standards and requirements for a GMP Certificate application.
• Information on GMP Documentary Evidence Verification (DEVA) or On Site GMP Audit.

• Act on incomplete or unclear information. Hence, to facilitate our timely follow-up/investigations, we appreciate if you could provide as much information possible such as the details about the seller (name, location, contact info), URL of the web posting, product information etc.
• Update you on the investigation status or outcomes of your feedback. This is important to maintain the integrity and confidentiality of the investigations.
• Advise you on matters such as refunds for your purchases or disputes arising from sale of goods. You may wish to approach the Consumer Association of Singapore (CASE) to seek assistance on your refund claim with the retailer.

To report illegal health products dealings/activities, please email hsa_info@hsa.gov.sg by stating your feedback clearly in the email subject.

• Advertisements and promotions of medicinal products for information on advertising guidelines, permit requirements, application procedures and fees.

• Processing time for each permit application is 14 working days.  

Regulatory self-help tools (For the industry)

• Medical Device Tools (All)
• Product Classification Tool
• Medical Devices Product Classification Guide 2148 KB
• Registration and licensing requirements tool
• Quick Guide to MD Registration and Licensing_May 2021227 KB
• Risk Classification Tool
• Grouping tool

You are encouraged to reference the Singapore Medical Device Register (SMDR) and guidance documents as additional guides to help you classify and/or group your devices.

All supporting documents which adequately validate the statements you have selected in the risk classification/grouping tool(s) must be submitted to substantiate the proposed risk classification/grouping category for your pre-market and/or change notification application.

Regulatory requirements

• Regulatory overview for medical devices
• Guidance documents for medical devices
• Fees and Turn-around-time

• Regulatory overview of therapeutic products
• Guidance on Therapeutic Product Registration in Singapore
• Fees and turnaround time
• PRISM application submission guides
• Common questions related to generic product registration, including choice of Singapore Reference Product or suitability of bioequivalence (BE) studies
• Submission of Drug Master File
• Retain, cancel or transfer therapeutic product registrations
• Special Access Routes
  • Import and supply of unregistered TP for patient’s use
  • Special consignment by a product registrant
  • Pandemic Special Access Route (PSAR)
  • Special access route for unauthorised COVID-19 vaccines
  • Import and supply of registered drug on consignment basis

 Tobacco licence application criteria and processes:

• Tobacco retail licence
• Tobacco import and wholesale licences
• Prohibition of harmful and imitation tobacco products
• Health warnings and labelling
• Standardised packaging for tobacco products