Page 6 - Malaysian-guideline-for-application-of-ctil-and-ctx-7th-edition

Malaysian Guideline for Application of CTIL and CTX

TABLE OF CONTENTS

FOREWORD ........................................................................................................................ iv

ACKNOWLEDGEMENTS ..................................................................................................... v
ABBREVIATION ................................................................................................................. viii

GLOSSARY .......................................................................................................................... ix

SECTION I ............................................................................................................................ 1
1. Introduction ................................................................................................................ 1

2. Registration of Clinical Trial with NMRR ..................................................................... 1
3. Products that Require CTIL/CTX ................................................................................ 2
4. Application Formalities for CTIL/ CTX ......................................................................... 2

4.1 Who can apply for CTIL/CTX ............................................................................... 2
4.2 Responsibility of the applicant.............................................................................. 2

4.3 Submission of CTIL/CTX application.................................................................... 3
4.4 Documents to be submitted in a new application for CTIL/CTX ............................ 3

4.5 Additional requirements ....................................................................................... 9
4.6 Administrative requirements .............................................................................. 10

5 Processing of CTIL/CTX Application ......................................................................... 12
5.1 Flow Chart: CTIL/CTX application process......................................................... 12
5.2 Flow Chart: CTIL/CTX application process involving First-in-Human
Clinical Trial ....................................................................................................... 13

5.3 Timelines ........................................................................................................... 14
5.4 Withdrawals of Application ................................................................................. 14

6 Decisions of the DCA ............................................................................................... 14
7 Conditions for CTIL/CTX .......................................................................................... 15
8 Withdrawal of CTIL ................................................................................................... 16

9 Reporting Amendment/ Update after CTIL/CTX Application is Approved .................. 16

9.1 Notification of amendment/ update ..................................................................... 16
9.2 Notification administrative requirement ............................................................... 16
9.3 Change of sponsor ............................................................................................. 17

10 Guidance for the Application of Variation .................................................................. 17
10.1 Expedited variation ............................................................................................ 17

10.2 Other variation ................................................................................................... 17
11 Safety Decision Arising from Report Analysis / by Other Regulatory Authority .......... 20
12 Interim Report ........................................................................................................... 20

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