The new guidelines aim to enhance efficiency in post-approval changes. From 1 June 2024, they will be tested in a one-year pilot study. The revised timelines vary from 10 to 150 working days depending on the type of product and variation.

Grouped applications are those that could take up to 150 working days. The original timelines are outlined in the Malaysian Variation Guideline for Pharmaceutical Products (MVG), Malaysian Variation Guideline for Biologics (MVGB), and Malaysian Variation Guideline for Natural and Health Supplement Products. 

NPRA noted that they encourage product registration holders to plan accordingly. However, applications exceeding the permitted variations will not be rejected but may face extended review periods. Overall, they stated that the new timelines should, ‘provide greater clarity and more effective monitoring’.

In addition, it was noted that applicants must attach a cover letter that summarizes the changes for each variation application. NPRA expects applicants to include information related to the proposed variation category, a brief description and justification of the proposed variation. If available, approvals from the country of origin's national regulatory agency or reference agencies should be included. 

Malaysia has a well-established biosimilars approval pathway, with guidance first published in 2008 that was based on the EMA’s approval system [1]. The country has now approved over 30 biosimilar products and if effective, these new variation timelines should strengthen their position. 

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars regulation, clinical trials, approval and adverse events in Malaysia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Nov 5]. Available from: www.gabionline.net/biosimilars/research/Biosimilars-regulation-clinical-trials-approval-and-adverse-events-in-Malaysia

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