Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Close this folder1. National drug regulation
Close this folderGuiding principles for small national drug regulatory authorities1,2
Open this folder and view contents1. General considerations
Open this folder and view contents2. Administrative aspects of the licensing process
Close this folder3. Technical aspects of the licensing process
View the document3.1 General considerations
View the document3.2 Products containing long-established chemical entities
View the document3.3 Products containing new chemical entities
View the document3.4 Herbal products
View the document3.5 Combinations of potent, therapeutically active substances
View the document3.6 Generic products
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 
3.2 Products containing long-established chemical entities

For products indicated for standard uses and that contain established ingredients, the following elements of information usually suffice as the basis both for a product licence and for a computerized data retrieval system:

- name of the product

- active ingredient(s) [by international nonproprietary name(s)]

- type of formulation

- therapeutic category

- quantitative formula (including excipients)

- quality control specifications

- indications, dosage, method of use

- contraindications, warnings, precautions

- bioavailability data (in vitro/in vivo)

- stability data, shelf-life

- container, packaging, labelling

- intended method of distribution: controlled drug; prescription item pharmacy sale; general sale

- manufacturer

- importer/distributor

- regulatory status in the exporting country.

If the dosage form is a novel one, such as a delayed-release tablet, or if a new route of administration is proposed, supporting data from clinical studies will be required.

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