To enhance the submission process, a dedicated Screening Package for New Drug Products and Biologics has been developed to provide clearer guidance and promote Good Submission Practice. This tool is designed to assist applicants in ensuring that their dossiers are complete and meet the necessary regulatory requirements prior to submission.
The Screening Package was presented and discussed during the Good Regulatory Practice Workshop on Screening Practices for New Drug Products and Biologics, held on 16th April 2025, reflecting our ongoing commitment to improving the quality and efficiency of regulatory submission. The package includes the following items, which are attached for your reference:
| No. | Screening Package | Remarks | Forms | Updated |
| 1. | A cover letter to describe the application |
Mandatory to be submitted during screening - to be attached under E14 and S10 |
June 2025 | |
| 2. | Screening Checklist |
Mandatory for all, except products submitted via the Facilitated Registration Pathway - to be attached under E14 and S10 - to provide applicant remarks only for the relevant fields, with further details as briefly outlined in the Cover Letter |
June 2025 | |
| 3. | Annex 2b |
Mandatory for products submitted via the Facilitated Registration Pathway - to be attached under E14 and S10 |
Download | June 2025 |
| 4. | Relevant forms | |||
| a) Applicant Declaration on Post-Marketing Commitments |
Mandatory for all products - to be attached under E12 |
Download | June 2025 | |
| b) ACTD Part III: Non Clinical Documentation - Good Laboratory Practice (GLP) Compliance Form |
Mandatory for all products, except Hybrids (Generic) - to be attached under E14 |
GLP Compliance Form | April 2024 | |
| c) Bioequivalence Study Report Submission Checklist |
Mandatory for Hybrids only (oral dosage form) - to be attached under P9 - other application forms and checklist relevant to bioequivalence studies can be found here. |
August 2024 |
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| 5. | Guidance for industry | Not to be submitted, serve as a guidance for applicants | Download | June 2025 |
We encourage applicants to immediately utilise this screening package when submitting new registration applications for New Drug Products and Biologics. Please note that, effective 16 June 2025, all applications must be accompanied by the screening package. To facilitate a smooth and efficient screening process, please ensure that all required documents and information are complete and submitted accurately.
