The Screening Package was introduced during the Good Regulatory Practice Workshop on 16 April 2025 and took effect on 16 June 2025. From this date onward, all applications must include a complete screening package.

Key mandatory components of the Screening Package include:

• A cover letter
• A screening checklist
• Applicant Declaration on Post-Marketing Commitments
• Asean Common Technical Dossier (ACTD) Part III: Non-Clinical Documentation – Good Laboratory Practice (GLP) Compliance Form
• Bioequivalence Study Report Submission Checklist 

The NPRA has published a detailed guidance to assist industry stakeholders with applications and the screening process [1]. 

Malaysia has a well-established biosimilars approval pathway, with guidance first published in 2008 that was based on the European Medicines Agency’s framework [2]. 

In 2024, the NPRA announced trialled new timelines for variation applications of registered pharmaceutical products and traditional and natural health supplements (TMHS) to improve efficiency in post-approval changes [3]. The new Screening Package is expected to further streamline the drug approval process in Malaysia.

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PanGen gains Malaysian approval for epoetin alfa biosimilar 

References
1. GUIDANCE FOR REGISTRATION APPLICATION FOR NEW DRUG PRODUCTS AND BIOLOGICS, CENTRE OF PRODUCT AND COSMETIC EVALUATION NATIONAL PHARMACEUTICAL REGULATORY AGENCY. Version 1.0, May 2025. Available from: https://www.npra.gov.my/images/2019/12/NCE/ScreeningPackage/GUIDANCE_FOR_REGISTRATION_APPLICATION_FOR_NEW_DRUG_PRODUCTS_AND_BIOLOGICS.pdf
2. 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 2025 Aug 25]. Available from: www.gabionline.net/biosimilars/research/Biosimilars-regulation-clinical-trials-approval-and-adverse-events-in-Malaysia

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