Drug Registration In Malaysia: A Complete Step-by-Step NPRA Submission Guide (2025 Update)

When it comes to drug registration in Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) is the key authority overseeing product evaluation, approval, and market entry.
 Preparing a compliant NPRA submission dossier is crucial for faster approvals, minimizing regulatory queries, and ensuring successful market access in Malaysia’s evolving pharmaceutical landscape.

This updated 2025 guide explains the 6 key steps to prepare a fully compliant NPRA drug registration dossier, aligned with the latest NPRA and ASEAN ACTD standards.

1. Understand NPRA Guidelines and Regulatory Requirements

Before starting the dossier preparation, review the latest version of the Drug Registration Guidance Document (DRGD) issued by NPRA.
 This document outlines administrative, technical, and scientific requirements for all types of drug applications — including new chemical entities (NCEs), generics, and biologics.

Staying aligned with NPRA updates and ASEAN regulatory harmonization ensures that your submission meets current Good Regulatory Practice (GRP) standards and avoids unnecessary rework or delays.

2. Structure the Dossier in the ACTD Format

Malaysia follows the ASEAN Common Technical Dossier (ACTD) format — a harmonized structure across ASEAN markets.
 The ACTD consists of four main parts:

• Part I: Administrative and Product Information
• Part II: Quality Document (CMC data, specifications, stability, etc.)
• Part III: Non-clinical Document (toxicology, pharmacology studies)
• Part IV: Clinical Document (clinical trial data, summaries)

Using the ACTD format not only ensures regulatory consistency but also simplifies future submissions in other ASEAN countries.

3. Conduct a Gap Analysis

Performing a regulatory gap analysis is one of the most critical early steps.
 This helps identify missing, outdated, or non-compliant documents — such as stability studies, manufacturing certificates, or product labelling discrepancies — before submission.

Proactively addressing these gaps enhances dossier quality and reduces the risk of NPRA clarification requests.

4. Ensure GMP Compliance

All manufacturing facilities involved in the product’s lifecycle must comply with NPRA’s Good Manufacturing Practice (GMP) standards.
 Manufacturers should possess a valid GMP certificate recognized by NPRA, in alignment with PIC/S GMP guidelines and related Annexes.

For overseas sites, NPRA may perform remote assessments or on-site GMP inspections to verify compliance.
 Maintaining up-to-date documentation and responding promptly to inspection queries is essential for timely approval.

5. Compile and Validate the Dossier Modules

During compilation, follow NPRA’s official checklists to ensure completeness.
 Key best practices include:

• Ensuring product labelling, packaging, and artwork comply with NPRA labelling requirements.
• Validating the electronic submission through the Quest3+ portal for technical accuracy.
• Verifying the inclusion of all required Certificates of Analysis (CoA), GMP certificates, and stability data.

A complete and validated dossier significantly improves regulatory review efficiency.

6. Submit via Quest3+ and Maintain Communication with NPRA

The Quest3+ system is NPRA’s centralized platform for dossier submission, evaluation tracking, and communication.
 After submission, maintain transparent and consistent communication with NPRA reviewers — responding quickly to queries or requests for clarification.

Timely follow-up and clear documentation foster a smooth review process and quicker market authorization.

Key Takeaways: NPRA Drug Registration Malaysia Process

Conclusion: Streamlining NPRA Compliance with Confidence

Preparing a compliant drug registration dossier in Malaysia requires a blend of regulatory knowledge, strategic planning, and technical accuracy.
 From ACTD formatting and GMP compliance to post-submission communication — every step influences your approval timeline and market success.

At Maven Regulatory Solutions, we help pharmaceutical companies navigate the NPRA registration process with precision — ensuring end-to-end regulatory compliance, GxP alignment, and faster approvals in the Malaysian and ASEAN markets.

With our deep expertise in regulatory dossier compilation, ACTD formatting, GMP compliance, and electronic submissions, Maven simplifies complexity — helping your products reach the market faster and safer.