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  Guidelines for Application of Clinical Trial Import Licence and Clinical Trial Exemption in Malaysia



Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption Edition 6.4 (PDF, 1.1MB)
FOREWORD

Since the last publication of Guideline for the application of Clinical Trial Import Licence (CTIL) and Clinical Trial Exemption (CTX) 5th Edition in 2009, we have witnessed robust growth in clinical research industry with the aim to achieve at least 1,000 clinical trials to generate GNI of RM578.4 million by the year 2020 in Malaysia. As one of the key players in attaining our national vision, the National Pharmaceutical Control Bureau takes a proactive role in optimising regulatory process by streamlining the existing guideline with the current needs, regulatory requirements and international standards.

This guideline, Malaysian Guideline for Application of CTIL and CTX in 6th edition supersedes the previous edition of guideline. This guideline shall also be read in conjunction with Malaysian Guideline for Safety Reporting of Investigational Products, 1stedition.

The significant amendments in this guideline include (but not limited to): changes in the format of the guideline, CTIL, CTX and variation application form, pharmaceutical data requirements, responsibility of holders, labelling requirements and clearer reporting amendment / update. The updated guideline shall assist sponsors, contract research organisations, local investigators and applicants in not only submission of applications for CTIL, CTX and variation but also reporting requirements after approval has been granted. Adherence to this updated guideline will facilitate the CTIL, CTX and variation 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 and stakeholders who have contributed to this guideline (October 2014). It is my hope that with this guideline will further contribute towards creating supportive ecosystem to grow clinical research in Malaysia.

 

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

October 2014

Malaysian Guideline for Application of Clinical Trial Import Licence and Clinical Trial Exemption Edition 6.4 (PDF, 1.1MB)

 



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