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:

• International Ethical Guidelines for Biomedical Research (CIOMS 2002)
   
• Operational Guidelines for Ethics Committees That Review Biomedical Research (WHO 2000)

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