Get In Touch:

Singapore Drug Product Registration

Pharmaceutical /Medicine/Drug/OTC registration in Singapore

MOH- Ministry of Health 

MOH Website- https://www.moh.gov.sg/

Regulatory Authority-Health Science Authority

Regulatory Website – https://www.hsa.gov.sg/ 

Local Representative Required –Yes

Classification Of drugs –

1.Prescription Only

2.Pharmacy Only Medicine

3.General Sale List 

NDA Approval Process

Pre-Submission Meeting

Application Submission

Administrative Review

Technical Assessment

Inspection of site

Approval Phase

Post Marketing Surveillance

  1. Pre-submission Meeting:

Before submitting a regulatory application, sponsors frequently meet with the regulatory agency. This meeting provides for conversations about the requirements, expectations, and any potential challenges associated with the approaching submission.

  1. Application submission

Following the pre-submission meeting, a formal application is filed to the regulatory agency. This application often includes detailed information about the medicine or medical product, such as preclinical and clinical study results, manufacturing facts, and other pertinent information.

  1. Administrative Review

Following submission, an administrative review is conducted to ensure that the application is full, accurate, and meets the basic regulatory criteria. This phase focuses on ensuring that the required paperwork and information are present.

  1. Technical Assessment

Once the administrative review is completed, the regulatory agency undertakes a thorough technical review of the given data. This involves examining the scientific and clinical data supporting the product’s safety, efficacy, and quality.

5.Inspection of Site

Regulatory bodies may undertake inspections of manufacturing plants and other relevant sites to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. This is critical for ensuring the quality and consistency of the production process.

6.Approval phase

After completing the evaluation and inspection procedures, the regulatory agency decides whether to approve the application. Approval indicates that the product meets regulatory requirements and can be advertised and sold.

7.Postmarketing Surveillance

Once a product is on the market, post-marketing surveillance is carried out to ensure its safety and effectiveness in real-world settings. This phase includes continuous data collection and analysis of adverse events and other pertinent information.

Generic Drug Approval Process     

Eligibility- The Drug product should be approved by any one Regulatory Agency.

Application Requirements-Submitted in eCTD Format. The Quality and Bioequivalence Studies documents are submitted in the dossier.

The Generic Drug Application is Submitted through PRISM.

Process

  1. 1. Submission of application in eCTD format.

The first step is to submit a regulatory application in eCTD format. This format is commonly used for electronic submissions of regulatory information to health authorities. The application will most likely include detailed information about the drug, such as its formulation, manufacturing procedures, quality control, and, if relevant, clinical trial results.

 2.Review of the Application.

Health officials, such as regulatory bodies, assess the application. This evaluation thoroughly examines the drug’s scientific, technological, and regulatory features. It evaluates if the drug meets the required standards of safety, efficacy, and quality.

3.Review and Assessment of Bioequivalence  

If the application is for a generic medicine or biosimilar, bioequivalence screening and assessment will most likely be prioritized. This entails comparing the generic or biosimilar product to the reference listed drug (RLD) or originator product to verify identical pharmacokinetic and pharmacodynamic properties. 

4.Approval of Application.

After completing the review procedure, the health authority decides whether to approve the application. Approval means that the medicine has met the relevant regulatory requirements and can be advertised and sold. The approval may be contingent on restrictions or requirements, and the product may be subject to post-market surveillance.

Biologics Approval Process

Submit the Application Through PRISM

Application Review

Assessment of Comparability

Approval of Application

  1. 1.Submit your application using PRISM.

    PRISM (Prescription Drug Information System) is a platform used by several regulatory authorities to submit and manage regulatory applications. This phase entails submitting the application, most likely in electronic format, via the PRISM system.

    2.Application Review.

    Following submission, regulatory authorities perform a thorough evaluation of the application. This study focuses on the product’s scientific, technical, and regulatory elements, including data on safety, efficacy, quality, and manufacturing methods.

    1. Assessment of comparability

    The term “comparability” is frequently used to indicate that a modified product (for example, a manufacturing process change) is comparable to the original or reference product. Comparability studies guarantee that changes to biologics do not have an impact on safety, effectiveness, or quality. This process may also apply to other items being modified. 

    4.Approval for Application

    After completing the review and comparability assessment, the regulatory agency decides whether to approve the application. Approval signifies that the product meets regulatory requirements and can be advertised and sold.

    Documents

     1.Drug master File

    2.Free Sale Certificate

    3.GMP Certificate

    4.Quality Documents

    5.Nonclinical Documents

    6.Clinical Documents. 

    FSC – Required

    License validity –12 months

    Labelling Requirements-English