Application of Clinical Trial Import Licence
FOREWORD
From the year 1999 since the Malaysian GCP Guidelines was implemented till the year 2003 there was a significant increase in the number of clinical trials conducted in Malaysia. With this great demand of clinical trials and to be in-line with the second edition of the Malaysian Guidelines for GCP - updated in January 2004, it is appropriate and timely that an update on the existing guideline on “Application of Clinical Trials Import Licence and Permit in Malaysia” is made available.
This updated guideline will assist the sponsor, local investigator and others involved in the application for a clinical trial import licence (CTIL) to import investigational product and/or an application for exemption to manufacture local product (CTX) for the purpose of clinical trials in Malaysia. This guideline is applicable for all medicinal products which are derived from biologicals, chemicals as well as from herbals/animals. Adherence to this guideline will facilitate the National Pharmaceutical Control Bureau in evaluating the application which may leads to a faster approval by the Drug Control Authority.
I would like to thank the Working Committee for all their efforts in the preparation of the fourth edition of “Guidelines For Application Of Clinical Trial Import Licence And Clinical Trial Exemption In Malaysia “ which will further promote the conduct of clinical trials in Malaysia.
Datin Hasiah binti Abdullah, Director National Pharmaceutical Control Bureau and Chairman of Working Group on the Guidelines for Application Clinical Trial Import Licence, Ministry of Health, Malaysia
December 2004
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