New Initiatives for Registration of Therapeutic Products Aug 2021

Online Self-guided Tool for Post-approval Minor Variation Applications and Updates on DMF submission

1. Introducing an Online Self-Guided Tool for Post-approval Minor Variation Applications

TPB has launched a new online self-guided tool for post-approval minor variation applications (MIV) to help industry stakeholders to get quick answers on the application type, variation category and documentary requirements for such variations. The tool also serves as an interactive guide to equip industry stakeholders with the regulatory information for good quality submissions, thereby enabling applicants to make the correct application type and submit the required supporting documents. 

This is part of HSA’s ongoing efforts to enhance clarity in our regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry. Industry stakeholders can now use this self-guided tool in lieu of sending email enquiries to TPB, which is faster and more convenient.

There are no technical changes made to the application types, variation categories or documentary requirements.

The tool may be accessed on the HSA website here.

2. Facilitating complete submission of Drug Master Files (DMFs)

Applicants can now use HSA’s acknowledgement email on the receipt of the Letter of Access from the DMF holder as documentary proof that all required documents from the DMF holder have been submitted to HSA. This will facilitate timely screening of the applications once submitted in PRISM and avoid any unnecessary screening queries and stop-clock for clarifying the status and completeness of the DMF. 

With effect from 1 September 2021, applicants are required to submit the aforesaid acknowledgement email for all registration applications that are supported by DMF. Please refer to the updated Appendix 11 here for information on the documentary requirements in support of a DMF submission. 

To enhance good submission practices by the industry, we have also provided further clarifications on the types of deficiencies that are considered major where the applications will not be accepted for screening. Please refer to Chapter B of the updated Guidance document here for more information. This will apply to applications submitted from 1 September 2021 onwards.

 

 

 

Published: 23 Aug 2021

Regulatory Updates