Singapore Drug Product Registration

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.

2. 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.

3. 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.

4. 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.