[ Download the Guidelines for Safety Reporting of Investigational Products here - PDF, 330KB ]

As Malaysia is increasingly involved in clinical trials, it is of utmost importance that the safety information generated from these trials be reported in a timely fashion to the regulatory authority. This is because the safety information of medicinal products in development is very limited and prompt reporting of such information is paramount to ensure the safety of clinical trial subjects as it enables action to be taken on any important safety data detected. Ultimately, the responsibility for the on-going safety evaluation of the medicinal product during the drug development cycle falls on the sponsors.

This guideline is developed to expand the scope and coverage of safety information reporting to the regulatory authority stated in the Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption 5th Edition and is adapted from the ICH Harmonised Tripartite Guideline E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting for use in Malaysia. This document will supersede the requirements stated in the Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption 5th Edition. All parties involved in conducting clinical trials in Malaysia are required to understand and adhere to the requirements of this guideline.

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

October 2014

[ Download the Guidelines for Safety Reporting of Investigational Products here - PDF, 330KB ]

 Print Friendly