CAMBODIA CHECK LIST FOR NEW REGISTRATION

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CAMBODIA CHECK LIST FOR NEW REGISTRATION
CAMBODIA CHECK LIST FOR NEW REGISTRATION
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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

[sociallocker id=7424]

CAMBODIA-CHECK LIST -New registration drug

[/sociallocker]

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

             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

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
Ngày viết:
Vietnam Regulatory Affairs Society. Join us, VNRAS, feel free to contact. We'll provide you all information and regulatory affairs update related to products covered by the Ministry of Health of Vietnam (drug, vaccine, biological, pharmaceutical raw material, excipient, capsule, traditional medicine, herbal medicine, medical equipment, invitro diagnostic medical devices, cosmetic, food supplements, chemical and preparation for medical and household use).
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