(1995; 156 pages)
International trade in pharmaceutical products encompasses many thousands of products. The value of the global pharmaceutical market is estimated to exceed US$ 200 billion per year. Some 20-30% of this amount involves international trade, while the remaining amount consists of drugs that are produced and consumed within individual countries. The dependence on imported pharmaceutical products differs between countries. In developing countries, particularly the least developed, the dependence on the importation of pharmaceutical products is much greater. In many cases it may reach 100%, as with Central African Republic, Fiji, Malawi, and Papua New Guinea, included in the present study.
The movement of pharmaceutical products in international commerce necessitates various safeguards on the part of importing countries and institutions to assure that pharmaceutical products are safe, effective, and of adequate quality when received.
The approach to quality assurance of pharmaceutical products includes a number of elements: a decision that the product is effective and safe; assurance of appropriate manufacturing conditions for its production and confirmation that these conditions fulfil requirements for Good Manufacturing Practices (GMP); and assurance of the quality of every batch through appropriate analytical testing. In the case of imported products, additional analytical testing is done to confirm that the batch received did not deteriorate in transit.
Looking at the administrative side, quality assurance of an imported product would ideally include the following elements:
a) registration of the product in the country of manufacture;
b) approval of manufacturing conditions by pharmaceutical inspection of the manufacturing plant;
c) quality analysis of a batch of the product by the manufacturer's laboratory before the product is released;
d) licensing of the product in the country of importation;
e) quality analysis of a sample of the product taken from every batch after receipt of goods at the country of destination.
Such an ideal situation is only rarely met in practice as it would require the existence and proper operation of regulatory authorities in both the exporting and importing countries and a considerable expenditure of resources. In most developing countries, the necessary resources are non-existent. The approaches used in practice by the majority of importing countries are, therefore, aimed at obtaining at least a partial assurance that imported products are licensed and approved for use in the country of origin, and are of acceptable quality.