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
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Open this folder and view contentsStability of drug dosage forms1
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Close this folderMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
View the documentIntroduction
View the documentGlossary
Close this folderPart One. Regulatory assessment of interchangeable multisource pharmaceutical products
View the document1. General considerations
View the document2. Multisource products and interchangeability
View the document3. Technical data for regulatory assessment
View the document4. Product information and promotion
View the document5. Collaboration between drug regulatory authorities
View the document6. Exchange of evaluation reports
Open this folder and view contentsPart Two. Equivalence studies needed for marketing authorization
Open this folder and view contentsPart Three. Tests for equivalence
View the documentPart Four. In vitro dissolution tests in product development and quality control
View the documentPart Five. Clinically important variations in bioavailability leading to non-approval of the product
View the documentPart Six. Studies needed to support new post-marketing manufacturing conditions
View the documentPart Seven. Choice of reference product
View the documentAuthors
View the documentReferences
View the documentAppendix 1. Examples of national requirements for in vivo equivalence studies for drugs included in the WHO Model List of Essential Drugs (Canada, Germany and the USA, December 1994)
View the documentAppendix 2. Explanation of symbols used in the design of bioequivalence studies in humans, and commonly used pharmacokinetic abbreviations
View the documentAppendix 3. Technical aspects of bioequivalence statistics
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. Technical data for regulatory assessment

For pharmaceutical products indicated for standard, well established uses and containing established ingredients, the following information, inter alia, should be provided in the documentation submitted with the application for marketing authorization and for inclusion in a computerized data retrieval system:

- the name of the product;

- the active ingredient(s) (designated by their international nonproprietary name(s)), their source, and a description of the manufacturing methods and the in-process controls;

- the type of dosage form;

- the route of administration;

- the main therapeutic category;

- a complete quantitative formula with justification and the method of manufacture of the dosage form in accordance with WHO GMP (2);

- quality control specifications for the starting materials, intermediates and final dosage form product, together with a validated analytical method;

- the results of batch testing together with the batch number and date of manufacture, including, where appropriate, the batch(es) used in bioequivalence studies;

- the indications, dosage and method of use;

- the contraindications, warnings, precautions and drug interactions;

- use in pregnancy and in other special groups of patients;

- the adverse effects;

- the effects and treatment of overdosage;

- equivalence data (comparative bioavailability, pharmacodynamic or clinical studies and comparative in vitro dissolution tests);

- stability data, proposed shelf-life, and recommended storage conditions;

- the container, packaging and labelling, including the proposed product information;

- the proposed method of distribution, e.g. as a controlled drug or a prescription item, and whether the product is intended for pharmacy sale or for general sale;

- the manufacturer and the licensing status (date of most recent inspection, date of licence and the authority that issued the licence);

- the importer/distributor;

- the regulatory status in the exporting country and, where available, summary of regulatory assessment documents from the exporting country, as well as the regulatory status in other countries.

If the dosage form is a novel one intended to modify drug delivery, e.g. a prolonged-release tablet, or if a different route of administration is proposed, supporting data, including clinical studies, will normally be required.

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