Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Close this folderIntroduction
View the documentNational drug regulation
View the documentProduct assessment and registration
View the documentGood manufacturing practices and inspection
View the documentDistribution
View the documentThe international pharmacopoeia and related activities
View the documentBasic tests
View the documentLaboratory services
View the documentInternational trade in pharmaceuticals
View the documentCounterfeit products
View the documentTraining
View the documentConclusion
Open this folder and view contents1. National drug regulation
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
 

Counterfeit products

Counterfeit pharmaceutical products present a new and serious threat to health care delivery. The alert was first given during the Conference of Experts on the Rational Use of Drugs, held in Nairobi in November 1985. In 1988, the Forty-first World Health Assembly adopted a resolution (WHA41.16) requesting governments and pharmaceutical manufacturers “to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations” and requesting the Director-General “to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations, and to cooperate with the Secretary-General of the United Nations in cases when the provisions of the international drug treaties are violated”. A joint WHO/International Federation of Pharmaceutical Manufacturers Associations workshop on counterfeit drugs was organized in Geneva in April 1992. The observations and recommendations published in the report of the workshop are contained in Chapter 8. Apart from the need for coordination and exchange of information between all interested parties, the recommendations stress the need for overall regulatory control through the setting up and strengthening of national drug regulatory and control authorities.

In 1995 a project was started to develop means to combat counterfeit drugs. Guidelines on drug inspection and the analysis of suspect samples have been prepared and a model training course on the application of these guidelines has been developed. A global workshop will be held at the end of 1997 to consider progress made and plan further activities.

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