Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia. Fifth Edition (Version 3.1), June 2009
(2009; 58 pages)

Abstract

Since the last update of the Guidelines for the Application of Clinical Trial Import License (CTIL) and Clinical Trial Exemption (CTX) in Malaysia in 2004, there has been significant changes in regulatory environment for clinical trial. The significant changes in this guideline amongst others include changes in the format of the guidelines, application forms for CTIL and CTX, reporting of serious adverse events, pharmaceutical data requirements for herbal/ natural products (Annex B1), responsibility of license holders, conditions for CTIL / CTX, labelling requirements, guidance for the application of variation, processing fee for CTIL renewal and product accountability and disposal. The updated guidelines shall assist sponsors, contract research organisations (CROs), local investigators and others in their applications for CTIL/ CTX. Adherence to these updated guidelines will facilitate the CTIL/ CTX applications leading to timely approval by the Drug Control Authority.

 
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