Singapore is becoming a global center for the pharmaceutical industry due to the cost-effective and reliable medical services, high-quality pharmaceutical manufacturing and research, access to regional markets, and a skilled workforce. Also, the Government has supported several schemes to drive innovation and development.

Singapore’s pharmaceutical market is driven by the growing healthcare demand and adoption of modern technology. Singapore invests a huge amount in the development of the healthcare system and Singapore’s healthcare system holds the sixth position worldwide as per WHO. 

Singaporean pharmaceutical market is expected to grow at a CAGR of 6.40% for the next ten years, and the total revenues of the Singaporean generics market were $0.4 billion in 2019. About 31.4% market share of prescription medicines in Singapore was generic drugs in 2017 and expected to reach 38.9% and about 567 million U.S. dollars by 2027.

Singapore has well-established pharmaceutical regulations among Asian countries. Let’s understand the regulations governing generic drugs for registration in Singapore.

What is a Generic drug in Singapore?

A generic drug application applies to therapeutic products that contain one or more chemical entities and is essentially the same as a Singapore Reference product in terms of its qualitative and quantitative composition of active ingredients.

Regulatory for Generic drug registration in Singapore

In Singapore, the Health Sciences Authority (HSA) is the regulatory authority for regulating pharmaceutical product registration.

Who can apply for registration?

In order to proceed with a therapeutic product registration in Singapore, you will need to be a local company registered with the Accounting and Corporate Regulatory Authority (ACRA).


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Generic drug application (GDA)

A generic drug application can be registered for a therapeutic product if it meets the following criteria:

  • The same pharmaceutical dosage form as the Singapore reference product.
  • Same administration route as the Singapore reference product.
  • Bioequivalent with the Singapore reference product.
  • Has conditions of use that fall within the directions for use (including dosing regimen, indication, and patient group) for the Singapore reference product.

Application types for generic drugs in Singapore

There are two types of generic drug applications (GDA) for registering generic drugs to be registered and marketed in Singapore.

  • GDA-1: This type of application is submitted for the first strength of a generic chemical product.
  • GDA-2: This type of application is submitted for the subsequent strength of the product that has been registered or submitted as GDA-1. The product name and dosage form must be the same as GDA-1.

Evaluation of generic drug application

Before applying for generic drug approval in Singapore, one needs to understand the requirements and regulations governing different evaluation routes for generic drugs.

There are three types of evaluation routes for generic drug registration in Singapore and are as follows

  1. Abridged evaluation Route 
  2. Verification evaluation route
  3. Verification evaluation route (CECA Scheme)

Application dossier format

Application dossier for generic drug application must be submitted in International Council for Harmonisation Common Technical Document (ICH CTD) or ASEAN CTD (ACTD) format. All the documents must be submitted in the English language.

How to submit a Generic drug application?

Application dossier is submitted online through PRISM (Pharmaceutical Regulatory and Information System. All administrative documents under Module 1 or Part I must be submitted in soft copy in PRISM and other parts of the documents may be submitted online via PRISM or in a CD/DVD labeled with the required information.

Timelines for screening and evaluation of GDA

  • Screening time for the application through three evaluation routes takes 50 working days. Screening time starts from the date of receipt of the application dossier.
  • The timeline may change or extended if the applicant is required to provide clarification or additional information in response to insufficient queries.

Notification of the Regulatory Decision

The applications are first screened for any deficiency and upon correction and fulfillment of details, the application is accepted for evaluation. After the evaluation of the applications, the regulatory decision will be notified as follows

  • Approval
  • Approvable
  • Non-approvable
  • Rejection

An approval decision for any therapeutic product given by HSA implies that the application satisfies the registration requirements for quality, safety, and efficacy.

After approval, the product is included in the Register of Therapeutic Products. A product registrant is responsible for ensuring the product’s quality, efficacy, and safety throughout its life cycle, and notification of post-approval changes if any must be given within a specified time.

Process flow

Processing fees for generic drug applications in Singapore

  • The applicant is charged with a screening fee on submission of the application and an evaluation fee upon acceptance of the application.
  • In Singapore, for a product to be maintained in the register, the applicant is charged an annual retention fee per registered product.

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References

  1. https://www.hsa.gov.sg/therapeutic-products/fees#toggle=togglepanel-dealer-s-licence-application
  2. https://www.hsa.gov.sg/therapeutic-products/dealers-licence
  3. https://www.guidemesingapore.com/business-guides/industry-guides/healthcare-industry/importing-healthcare-products-into-singapore-part-2-importing-western-medicine
  4. https://pharmexcil.com/v1/docs/CountryWise/Singapore_Pharmaceutical.pdf
  5. https://www.rajahtannasia.com/media/3229/lan-a-comparative-overview-of-distribution-and-marketing-of-drugs-across-asia-pacific.pdf
  6. https://www.hsa.gov.sg/therapeutic-products/register/guides/generic-drug/abridged-evaluation
  7. https://www.hsa.gov.sg/therapeutic-products/register/guides/generic-drug/verification-evaluation
  8. https://www.hsa.gov.sg/therapeutic-products/fees#toggle=togglepanel-product-registration-for-generic-drug-application
  9. https://www.hsa.gov.sg/therapeutic-products/register/overview/overview
  10. https://www.hsa.gov.sg/therapeutic-products/dealers-licence