Consultation Information

Ministry/Agency Ministry of Health Malaysia - National Pharmaceutical Regulatory Agency
Consultation Period 16/01/2026 - 10/03/2026 Closed
Consultation Stage Public Feedback
Classification Professional, scientific and technical activities

Purpose

This public consultation aims to gather stakeholder feedback on the rebranding of the NPRA GLP Compliance Programme Manual to the Malaysian Guideline for NPRA GLP Compliance Programme, and to enhance transparency and understanding of regulatory expectations prior to finalisation.

Affected Stakeholder

- GLP test facilities (listed, applying, or previously inspected)
- Study sponsors, including pharmaceutical/medical device companies and contract research organisations
- Quality assurance personnel and GLP professionals
- Regulatory authorities and relevant government agencies
- Industry associations and professional bodies
- Academic and research institutions conducting non-clinical studies
- International stakeholders subject to NPRA GLP compliance monitoring

Documents

Main Consultation Document
GLP_Compliance_Programme_Guideline 2026 (20260106) UPC.pdf
Main Consultation Document â€ĸ 1.14 MB
Download

Have Your Say

Share your thoughts and feedback

Engage with stakeholders and provide administrative oversight on feedback.

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Survey

Please indicate the relevant line number(s) of the draft Malaysian Guideline for NPRA GLP Compliance Programme that you wish to comment on, followed by your comments or suggested amendments in the space provided. Each comment should be clearly linked to the corresponding line number to facilitate review and consolidation.

The cooperation of Dato'/Datin/Dr./Sir/Madam is requested to complete ALL the details in the survey. All information is confidential and will be used for the purpose of this public consultation session only. We would like to thank you for your time and effort in providing feedback.

Please click on the button below to contribute your comment to this consultation.

Officer to Contact

Contact 1
Nik Juzaimah Juhari
Contact Person
nikjuzaimah@npra.gov.my
Email
0378835487
Phone
Contact 2
Fauziah Mohamed Kasim
Contact Person
fauziah@npra.gov.my
Email
0378835482
Phone
Contact 3
LIM WEN JUN
Contact Person
wjlim@npra.gov.my
Email
0378835483
Phone