Malaysia’s NPRA Guidance: Drug Registration Guidance, What’s Inside?

On 22nd July 2025, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released the Third Edition, Tenth Revision of the "Drug Registration Guidance Document (DRGD)". This comprehensive guide remains the central reference for the registration, quality control, inspection, licensing, and post-registration activities of medicinal products for human use in Malaysia.

The DRGD was first published in hardcopy in the 1990s, then consolidated into an online document in 2004, with major revisions in:

• 2013: First Edition (complete restructuring)

• 2016: Second Edition (reflecting NPRA’s name change)

• 2021: Third Edition (due to NPRA’s restructure)

• July 2025: Tenth Revision (latest update)

NPRA updates the DRGD to keep Malaysia aligned with international standards such as WHO and ICH, and to ensure transparency, clarity, and harmonisation with ASEAN technical requirements.

The main document is divided into five sections:

1. General Overview – definitions, classification, exemptions

2. Product Registration Process – how to apply, fees, screening, evaluation, and appeal

3. Quality Control – analytical requirements

4. Inspection, Licensing, Certificates

5. Post-Registration Process – variations, pharmacovigilance, quality monitoring, product recall

Plus 33 detailed appendices covering topics from bioequivalence and priority review to labelling, orphan medicines, and appeal processes.Products that must be registered include:

• Medical Device-Drug-Cosmetic Interphase (MDDCI) and Combination Products 👉 Appendix 2

• New Drug Products 👉 Appendix 3

• Biologics 👉 Appendix 4

• Generics 👉 Appendix 5

Key Registration Requirements

• Only a locally incorporated company (Product Registration Holder, PRH) may apply

• Applications must be submitted via the online QUEST system

• Applicants must follow the ASEAN Common Technical Dossier (ACTD/ACTR)

• Different product types (new drugs, biologics, generics) have specific data requirements

• Registration numbers: products intended only for export receive an “E” suffix (e.g., MALxxxxE)

• Annual updates, risk communication, and reporting are mandatory after approval

Post-Registration Activities

After approval, PRHs must:

• Monitor product quality (PQM programme)

• Submit pharmacovigilance data

• Report variations (minor or major)

• Manage recalls quickly and transparently

• Keep NPRA updated on any manufacturer or ownership changes.

All applications must go through NPRA’s secure portal: QUEST system login. For more details, read the full guidance:

• NPRA DRGD main page

• Full DRGD PDF (July 2025)