Malaysia announces Screening Package for new drugs and biologicals

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Malaysia announces Screening Package for new drugs and biologicals

Home/Policies & Legislation | Posted 25/08/2025 0 Post your comment

To enhance the submission process for new drugs and biological products, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has developed a dedicated a dedicated Screening Package. This initiative aims to provide clearer guidance and promote Good Submission Practice by helping applicants ensure their dossiers are complete and meet regulatory requirements before submission.

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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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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Source: NPRA, Ministry of Health Malaysia