文档介绍：1. INTRODUCTION
. MON TECHNICAL DOCUMENT
From 1st July 2003, all new applications should be made in accordance with the EU-CTD. The layout of the CTD is essentially a reordering of the presentation of the data in the case of the Part II Chemical, Pharmaceutical and Biological Documentation. Part II now es Module 3, and whilst it has all the data of the former Part II it is set out in a different order. The major change is to remove the old Part IIC Section 1 – Active Ingredient(s) plus Part IIF 1 Stability of Active Ingredient, and bring it forward to the front of Module 3 and rename it under the general heading
. DRUG SUBSTANCE
the balance of the old Part II es under the general
. DRUG PRODUCT
thus we will now follow the USA FDA in the general terminology, and “Active Ingredient” and “Dosage Form” should theoretically fall out of usage, whoever this I am sure will take some time in Europe. The following statement is taken out of the Presentation and Content section of the CTD (May 2002)
THE EUROPEAN DRUG MASTER FILE.
A Table of Contents for the CTD Module . Drug Substance dossier should be provided.
. 1 GENERAL INFORMATION
Nomenclature
Information on the nomenclature of the drug substance should be provided. For example:
mended International Non proprietary Name (INN);
Compendial (. European Pharmacopoeia) name if relevant