Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia (PDF, 487KB)

FOREWORD

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. Thus, it is timely and appropriate to streamline the existing guidelines in accordance with the current needs, regulatory requirements and international standards.

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 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.

I would like to take this opportunity to extend my deepest appreciation to all the committee members who have contributed in one way or another to making this 5th edition of the guidelines (June 2009) a reality. It is my hope that with these guidelines will further contribute towards strengthening and promoting Malaysia as a clinical trial hub in this region.

Selvaraja Seerangam
Director of Pharmacy Regulatory
National Pharmaceutical Control Bureau
Ministry of Health, Malaysia

June 2009

Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia (PDF, 487KB)

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