This document outlines the requirements for registering an imported pharmaceutical product in Laos. It lists 4 parts that must be submitted with an application:
Part I requires administrative information like an application form and documentation of approvals.
Part II focuses on quality documents about the drug substance and product.
Part III requires non-clinical documents including pharmacology, pharmacokinetics, and toxicology summaries.
Part IV covers clinical documents such as an overview, efficacy and safety summaries, and published clinical papers. The required parts vary depending on if the application is for a new, generic, or existing product.
Original Description:
laos, _registration of Imported_Medicines
Original Title
Check_List_Form_ No_ 2_registration of Imported_Medicines
This document outlines the requirements for registering an imported pharmaceutical product in Laos. It lists 4 parts that must be submitted with an application:
Part I requires administrative information like an application form and documentation of approvals.
Part II focuses on quality documents about the drug substance and product.
Part III requires non-clinical documents including pharmacology, pharmacokinetics, and toxicology summaries.
Part IV covers clinical documents such as an overview, efficacy and safety summaries, and published clinical papers. The required parts vary depending on if the application is for a new, generic, or existing product.
This document outlines the requirements for registering an imported pharmaceutical product in Laos. It lists 4 parts that must be submitted with an application:
Part I requires administrative information like an application form and documentation of approvals.
Part II focuses on quality documents about the drug substance and product.
Part III requires non-clinical documents including pharmacology, pharmacokinetics, and toxicology summaries.
Part IV covers clinical documents such as an overview, efficacy and safety summaries, and published clinical papers. The required parts vary depending on if the application is for a new, generic, or existing product.
Checklist of Requirements for the Registration of Import Pharmaceutical Product
Item Parameters Copies FDD use only
PART I. ADMINISTATIVE AND PRESCRIBING INFORMATION Section A FDD Application Form No. 2 Section B Applicant nomination certified by the manufacturer of the Product Supplementary Documentation Section C Stage 1 Approval Letter Certificate of Pharmaceutical Product (CPP) Certificate of Drug Registration (CoR) Certificate of Good Manufacturing Practice (GMP) Certificate of Free sale (CFS) Summary of Product Characteristics PART II. Quality Documents Section A Tablet of contents Section B Quality of contents Body of Data - Drug Substance - Drug Product - List of Key Literature Reference PART III. Non Clinical Document Section A Table of contents Section B Non-clinical Overview Section C Non-clinical Written and Tabulated Summaries - Table of Contents - Introduction - Pharmacology Written Summary - Pharmacology Tabulated Summary - Pharmacokinetics Written Summary - Pharmacokinetics Tabulated Summary - Toxicology Written Summary - Toxicology Tabulated Summary Section D Non-Clinical Study Summary Section E List of Key Literature Reference PART IV. Clinical Document Section A Table of Contents Section B Clinical Overview Section C Clinical Summary - Summary of Bio-Pharmaceutics and - Associated Analytical Methods - Summary of Clinical Pharmacology Studies - Summary of Clinical Efficacy - Summary of Clinical Safety - Tabulated Listing of all Clinical Studies - List of Key Literature References - Published Clinical Paper
Note: Data to be submitted will be based on each application type as follow:
New Product - Parts I to IV (except for existing chemical or biological entity (s) in a new dosage form which will require only Parts I & II, together with pharmacokinetic data) Generic product-Parts I & II
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