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Good Clinical Practice (GCP)
Guideline on the Use of Human Biological Tissues for Research
Guidelines for Ethical Review of Clinical Research or Research involving human subjects
Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia
Guidelines for Good Clinical Practice (GCP) Inspection
Malaysian Guideline for Safety Reporting of Investigational Products
Malaysian Guideline for Independent Ethics Committee Registration and Inspection
Malaysian Guideline for Bioequivalence Inspection
International Ethical Guidelines for Biomedical Research (CIOMS 2002)
Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO 2000)
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  Services

The following list several of NCCR’s significant contributions:

•  Established the guidelines for accreditation of clinical research centres
•  Developed and published the Malaysian Good Clinical Practice Guidelines
•  Developed the curriculum and requirement for conducting GCP training courses
•  Initiated and carried out a series of national GCP training course for trainer/clinical researcher
•  Established the procedure for the accreditation of clinical facilities to conduct GCP compliant studies
•  Undertook preliminary inspection visits to major hospitals/clinical facilities and advised on steps that needed to be carried out to attain compliance
•   Initiated and carried out introductory courses in Good Laboratory Practices
•   Developed the guidelines for the conduct of Bio-equivalence evaluation for the generic pharmaceuticals
•  Undertook a review of current practices for ethical approval in Malaysia and established mechanism to harmonize approval standard and procedures 
•  Developed a series of guidelines for the conduct of clinical studies for herbal products.

Guidelines

» Good Clinical Practice (GCP)

» Guideline on the Use of Human Biological Tissues for Research

» Guidelines for Ethical Review of Clinical Research or Research involving human subjects

» Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption, Edition 6.4

» Guidelines for GCP Inspection

» Malaysian Guideline for Safety Reporting of Investigational Products 1st Edition

» Malaysian Guideline for Independent Ethics Committee Registration and Inspection 1st Edition

» Malaysian Guideline for Bioequivalence Inspection, 1st Edition

 

For your convenience, we have the following guidelines featured as well:

 



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