(1995; 156 pages)
Safety, quality and efficacy of pharmaceutical products moving in international markets have always been of great concern to WHO. In this regard, WHO created the Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, among other mechanisms, as a means of assisting Member States to improve their national systems for quality assurance of drugs.
In 1981, the WHO Action Programme on Essential Drugs was established to cooperate with Member States, particularly developing countries, with the aim of making universally accessible the most needed drugs in support of primary health care.
In 1992, the two Divisions concerned with pharmaceutical products in WHO, the Action Programme on Essential Drugs and the Division of Drug Management and Policies, in cooperation with the USFDA and USAID, undertook a research project to determine to what extent the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce was used and also to identify the needs and concerns of Member States with regard to the application and use of the Scheme. This report is the result of the research, carried out in 17 countries, in which over 40 technical officers participated.
It is hoped that the findings of the research will contribute to the wider understanding and use of the Scheme as well as the constant improvement of this very important tool for quality assurance of pharmaceutical products.
Dr Fernando S. Antezana
Geneva, 12 December 1994