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
1. General considerations

The national health authorities (national drug regulatory authorities) should ensure that all pharmaceutical products subject to their control are in conformity with acceptable standards of quality, safety and efficacy, and that all premises and practices employed in the manufacture, storage and distribution of these products comply with GMP standards so as to ensure the continued conformity of the products with these requirements until such time as they are delivered to the end user.

These objectives can be accomplished effectively only if a mandatory system of marketing authorization for pharmaceutical products and the licensing of their manufacturers, importing agents and distributors exists and adequate resources are available for implementation. Health authorities in countries with limited resources are less able to perform these tasks. To assure the quality of imported pharmaceutical products and drug substances, they are therefore dependent on authoritative, reliable, and independent information from the drug regulatory authority of the exporting country. This information, including information on the regulatory status of a pharmaceutical product, and the manufacturer’s compliance with GMP (2) in the exporting country, is most effectively obtained through the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce [see pp. 187-209], which provides a channel of communication between the regulatory authorities in the importing and exporting countries (see World Health Assembly resolutions WHA41.18 and WHA45.29).

The essential functions and responsibilities of a drug regulatory authority have been further elaborated by WHO in the guiding principles for small national drug regulatory authorities (3, 4).

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