Guidance: Early Access to Medicines Scheme – Information for Applicants

NPRA Pilot Project on Post-Approval Changes in Product Registration

The National Pharmaceuticals and Therapeutics Authority (NPRA) is conducting a pilot project to evaluate the effectiveness of reliance for post-approval changes in product registration. The objective is to reduce timelines and enhance efficiency in the registration process. Key details include:

• Participant Requirements: Applicants must submit:
• Letter of Intent
• Official approval letter from a reference agency
• Assessment report
• &A documentation
•  Summary of changes

Timeline:

• For MaV/MaVB variations: 100 working days
• For variations excluding MaV/MaVB: 80 working days

Submission Process:

• Submit a variation application via Quest 3+
• Use variation category MiV-N
• Notify the Head of Section via email
  

The project is set to conclude by 01-Jun-2025, with the aim of streamlining the approval process and improving overall efficiency.

Region:Malaysia

Source: https://npra.gov.my/index.php/en/component/content/article/225-english/1527676-announcement-to-product-registration-holders-prhs-pilot-project-for-post-approval-changes-variation-using-reliance.html?Itemid=1391