CAMBODIA CHECK LIST FOR NEW REGISTRATION
CAMBODIA CHECK LIST-VERSION 00
I : ACTD SECTION ( drug-ethical , OTC) :
a): Brief recommendation on how to prepare the registration dossier as per ACTD format.
b): Introduction ( about the product )
c): Letter of Authorization
d): Table of contends
DOWNLOAD REQUIREEMENTS AND FORMS FOR REGISTRATION HERE
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CAMBODIA-CHECK LIST -New registration drug
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Other information from Cambodia here
TABLE OF CONTENTS
Product Name : …………………………………
| No. | Document | Pages |
| Part I: Administrative and Product Information | ||
| 1 | Application Form For Market Authorization | |
| 2 | GMP Certificate | |
| 3 | Certificate of Pharmaceutical Product | |
| 4 | Summary of Product Characteristics | |
| Part II : Quality | ||
| 6 | Section A : Table of Contents | |
| 7 | Section B: Quality Overall Summary (QOS) | |
| S- Drug Substance | ||
| P- Drug Product | ||
| 8 | Section C: Body Data | |
| S- Drug Substance
– General information – Manufacturer – Characterization – Control of drug substance – Reference standard or materials – Container closure system – Stability |
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| P- Drug Product
– Description and composition – Pharmaceutical development – Manufacturer – Control of excipients – Control of finished product – Reference standard or materials – Container closure system – Stability – Product interchangeability |
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| 9 | Section D: Key Literature Reference | |
| Part III: Non-Clinical | ||
| 10 | Section A: Table of Contents | |
| 11 | Section B: Non-clinical Overview | |
| 12 | Section C: Non-clinical Written and Tabulated Summaries | |
| 13 | Section D: Non-clinical Study Report | |
| Part IV: Clinical Data | ||
| 14 | Section A: Table of contents | |
| 15 | Section B: Clinical Overview | |
| 16 | Section C: Clinical Summary | |
| 17 | Section D: Tabular Listing of All Clinical Studies | |
| 18 | Section E: Clinical Study Reports | |
| 19 | Section F: List of Key Literature References |
 Table of contents for drug registration){kind=link}