(1995; 156 pages)
2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
During the last two decades WHO has promoted the use of the WHO Certification Scheme particularly by importing countries of the developing world who, for various reasons, may be vulnerable to problems associated with pharmaceutical products that do not meet specifications. These countries often do not have the national laboratories required to verify the quality of drugs.
Since the introduction of the Scheme, there have been important changes in the nature and scope of the international market in pharmaceutical products. Many more countries are now involved in the export of drugs so that there is no longer a limited number of primary sources in a few major industrial countries. In addition, the opportunities for re-packaging and labelling have grown to further complicate the issuance of a Certificate of a Pharmaceutical Product by a national regulatory authority.
It has also become clear that the exact forms of the WHO Certification Scheme, as described above, have not yet been applied to most of the pharmaceutical products moving in international trade. When this is coupled with the serious problems of sub-standard drugs moving in international commerce, particularly to developing countries, it is clearly important to assess the practical application of the Certification Scheme.
The Action Programme on Essential Drugs (DAP), with the financial support of USAID's Office of Health, therefore, decided to carry out an independent assessment of the use of the Certification Scheme in drug procurement/supply systems and current mechanisms of drug quality assurance, in order to examine its effectiveness and enhance its wider use.