NPRA has been conducting a pilot project to explore the use of reliance for post-approval changes (variation). This initiative is on-going and is expected to conclude by 1 June 2025.

This pilot will help us assess the effectiveness of utilising reliance approach for post-approval changes, aiming to reduce timelines and improve efficiency.

Requirements for this pilot are as follows:

1. A Letter of Intent (LOI)/ cover letter to use reliance for the application.
2. Official approval letter or notification of the post-approval changes from chosen reference agency/ WHO.
3. Assessment report from chosen reference agency. In particular, if details of the approved changes are not included in the approval letter, the assessment report will be required. For biologic products, the assessment report is required at the time of submission.
4. Q&A documentation will be requested during evaluation if required.
5. An overall summary of changes. A comparative tabulated format showing both the approved and proposed changes should be provided, where applicable.

Please ensure that the variations submitted are in accordance with those submitted in the reference agency. The timeline for this reliance pathway will be as follows:

It is not advisable to bundle them with other variations that are not part of the reliance submission. The timeline above will not be applicable if the submission includes other variations that are not part of the reliance submission.

Steps for submission:

1. Submit a variation application through Quest 3+ in accordance with the variation categories outlined in the Malaysian Variation Guideline for Pharmaceutical Products, 2^nd Edition (July 2022) or Malaysian Variation Guideline for Biologics (MVGB), 1st edition (Jan 2017).
2. In your online variation submission, please also add the variation category MiV-N (Post-approval Changes Reliance Pilot Project) to identify the application as a reliance application.
3. Notify the respective Head of Section via email regarding the reliance application.

Applicants are advised to consult the respective Head of Sections if there are any queries.

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