As part of HSA’s ongoing efforts to enhance clarity in regulatory requirements and processes, and make regulatory information easily accessible to encourage good submission practices by the industry, the HSA has introduced an online self-guided tool for post-approval minor variations application and a DMF acknowledgment email and guidance on deficiency matters.
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.
There are no technical changes made to the application types, variation categories or documentary requirements.
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.
Acknowledgement emails: in effect
With effect from 1 September 2021, applicants are required to submit the aforesaid acknowledgement email for all registration applications that are supported by DMF.
DMF guidance on Deficiencies
To enhance good submission practices by the industry, the HSA has provided further clarifications on the types of major deficiencies that cause applications to be rejected.
Please refer to Chapter B of the updated Guidance. This will apply to applications submitted from 1 September 2021 onwards.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.