[ Download the Malaysian Guideline for Independent Ethics Committee Registration and Inspection here - PDF, 763KB ]

The Drug Control Authority (DCA)'s mission is to ensure the implementation of Good Clinical Practice (GCP), which is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Ethnics committees play a crucial role in assessing the scientific and ethical aspects of a clinical trial to safeguard the rights, safety and well-being of clinical trial subjects. In recent years, National Pharmaceutical Control Bureau, in particular of Center for Investigational New Products has expanded its activities in ethical committee inspections. 

The DCA is at the forefront to create an eco-system environment in clinical research platform to ensure all parties involved in clinical trials in Malaysia comply with the principles embossed in the GCP. Independent ethics committee inspection plays an important role in upholding the quality conduct of an ethic committee in line with international ethical practice and requirements. 

This guideline, Malaysian Guideline for Independent Ethics Committee Registration and Inspection, 1st edition specifically narrates the registration process for a new ethical committee, conduct of ethical committee inspection and administrative maintenance of ethical committee with DCA. This guideline supersedes the appendix Vi in the Guideline for Good Clinical Practice Inspection Programme.

I would like to express my deepest appreciation to the committee members and stakeholders whom inspired and shared their insight to develop this guideline. It is my pleasure that this guideline will contribute to catalyst the process of ethics committee registration and inspection. 

Tan Ann Ling
Director of Pharmacy Regulatory
National Pharmaceutical Control Bureau
Ministry of Health Malaysia

May 2016

[ Download the Malaysian Guideline for Independent Ethics Committee Registration and Inspection here - PDF, 763KB ]

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