Malaysia: Mandatory Screening Package for New Drug and Biologic Registrations (effective from 16 June 2025

In a continued effort to strengthen the quality and efficiency of regulatory assessments, the National Pharmaceutical Regulatory Agency (NPRA) has announced the mandatory submission of a Screening Package for new registration applications involving New Drug Products and Biologics. From 16 June 2025 onward, all applications for the registration of New Drug Products and Biologics must include the Screening Package.

What Is the Screening Package?

The Screening Package is a comprehensive set of documents and forms that must be submitted together with new product registration applications. Its purpose is to:

• Facilitate quicker and more effective screening

• Ensure completeness and consistency of submitted information

• Reduce back-and-forth queries that can delay the registration process

  
  

This screening requirement is part of NPRA’s continued efforts to enhance regulatory standards and align local practices with international expectations.

What Does the Screening Package Include?

Who Needs to Comply?

This new requirement applies to:

Compliance Negligence

Applications without the Screening Package will not be accepted. This means delays in the product registration timeline and potential disruption to product launch schedules.

To avoid processing delays:

• Ensure your submission include all required documents as outlined in the Screening Package

• Refer to the latest guidelines and submission checklist provided by NPRA

  
  

Why It Matters

NPRA strongly encourages applicants to enforce the usage of the Screening Package immediately as it will help teams to identify gaps, adjust workflows, and ensure smoother transactions.

This move by NPRA signals an important shift toward more structured and efficient regulatory processes, especially for complex therapeutic products. For companies operating in the biologics and new drug space, compliance with this new requirement is essential for uninterrupted market access in Malaysia.

Source: National Pharmaceutical Regulatory Agency (NPRA)