Guidelines
Directive For Receiving Application Of CTIL/CTX Involving First In Human Clinical Trial : Directive Of Senior Director Of Pharmaceutical Services MOH Bil 4/2019 01/02/2019
Attachments
Directive of Director of Pharmaceutical Services on Clinical Trial Registration 10/12/2009
Attachments
Director General of Health Circular Bil 3/2017 On NIH Guidelines For Application Of Ministry Of Health (MOH) Research Grant (MRG)
-
Attachments
Director General of Health Circular Bil 4/2015 On Procedure And Workflow Submission For Research On Stem Cell & Cell-based Therapies 02/04/2015
Attachments
Director General of Health Circulars on NIH Guidelines For Conducting Research in Ministry Of Health (MOH) Institutions And Facilities
- Director General of Health Circular Bil 4/2022 on NIH Guidelines For Conducting Research in Ministry Of Health (MOH) Institutions And Facilities (3rd Edition/2021) 31/01/2022
- Director General of Health Circular Bil10/2015 on NIH Guidelines For Conducting Research in Ministry Of Health (MOH) Institutions And Facilities (Revision 01/2015) 21/10/2015
- Director General of Health Circular Bil10/2015 on NIH Guidelines For Conducting Research in Ministry Of Health (MOH) Institutions And Facilities (Revision 01/2015) 21/10/2015
- Director General of Health Circular Bil 9/2007 on NIH Guidelines For Conducting Research in Ministry Of Health (MOH) Institutions And Facilities 05/09/2007
Attachments
General Circulars On Regulations For Conducting Research in Malaysia (EPU)
- Regulations For Conducting Research In Malaysia (EPU) General Circular Bil 2/2011 : Amendment of General Circular Bil 3/1999 14/02/2011
- Regulations For Conducting Research In Malaysia (EPU): General Circular Bil 3/1999 31/07/1999
**For more information on the requirement & related procedure, kindly visit: https://www.epu.gov.my/en/resources/guidelines-and-procedures/undertaking-research-malaysia
- Regulations For Conducting Research In Malaysia (EPU): General Circular Bil 3/1999 31/07/1999
**For more information on the requirement & related procedure, kindly visit: https://www.epu.gov.my/en/resources/guidelines-and-procedures/undertaking-research-malaysia
Attachments
Guidelines for Application of Clinical Trial Import License And Clinical Trial Exemption In Malaysia 7.1th Edition 2021
Guidelines for Application of Clinical Trial Import License And Clinical Trial Exemption In Malaysia 7.1th Edition 2021
Attachments
Guidelines For The Conduct Of Bioavailability And Bioequivalence Studies
- ASEAN Guidelines For The Conduct Of Bioequivalence Studies 2015 (Adopted By Malaysia-NPRA since March 2015)
- Malaysian Guidelines For The Conduct Of Bioavailability And Bioequivalence Studies 2000 : 04/09/2000
- Malaysian Guidelines For The Conduct Of Bioavailability And Bioequivalence Studies 2000 : 04/09/2000
Attachments
Guidelines on Conducting Research under Pharmaceutical Services Programme in Ministry of Health Malaysia 2nd Edition 2022
Garis Panduan Menjalankan Penyelidikan di Program Perkhidmatan Farmasi, Kementerian Kesihatan Malaysia Edisi Kedua (2022)
Attachments
Letter From Director General Of Health On The Conduct Of Pharmacogenomics And Pharmacogenetics Studies In Ministry Of Health (MOH) 07/06/2010
Attachments
Letter From Director General Of Health On The GCP Requirement For Investigators Involved In Clinical Trial 08/10/2010
Attachments
Letter From Director General Of Health To Sponsors : Management Fees For Industry Sponsored Research (ISR) 06/11/2012
Attachments
NIH Guidelines For Conducting Research in Ministry Of Health (MOH) Institutions And Facilities 2015
Revision 1/2015, 2nd Edition
Attachments
International Ethical Guidelines for Health-related Research Involving Humans
Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
Attachments
Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
This Standards Operational Guidance is Issued by the World Health Organisation (WHO) in 2011
Attachments
ICH Harmonised Guideline For Good Clinical Practice (E6R2)
dated 9 November 2016
Attachments
NIH Guidelines For Conducting Research In Ministry of Health Institutions & Facilities 3rd Edition 2021
This updated guideline is compiled to help investigators from MOH as well as others who are involved in the conduct of any research involving the MOH facilities, subjects, samples or data. All requirements and information in this document were adapted from both international and local guidelines and regulations.
Attachments
Notification Of Exemption From Registration Of Medical Devices For The Purpose Of Clinical Research Or Performance Evaluation, 1st Edition 2017
- Notification Of Exemption From Registration Of Medical Devices For The Purpose Of Clinical Research Or Performance Evaluation, 1st Edition April 2017
Attachments