(1995; 156 pages)
A comprehensive system of quality assurance of pharmaceutical products must be based on a reliable system of evaluation and registration to establish safety and efficacy, analysis of the quality of the finished product, and confirmation through inspection that the manufacturing conditions fulfil requirements for Good Manufacturing Practices.
Such an ideal situation is only rarely met in practice, especially in developing countries, where financial resources and technical skills to set-up national quality assurance systems are not easily available.
In order to meet the needs of developing countries, the World Health Assembly adopted the World Health Organization (WHO) Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce in 1975. The Scheme has been revised twice since 1975: once in 1988 and again in 1992. As at December 1994, 138 Member States, both importing and exporting pharmaceutical products, are signatories to the Scheme.
Twenty years after the Scheme was introduced it became evident that the exact formats of the Scheme, as recommended by WHO, had not yet been applied to most of the pharmaceutical products moving in international commerce. The Action Programme on Essential Drugs (DAP), in collaboration with the Division of Drug Management and Policies (DMP) and the Office of Health, US Agency for International Development, therefore, at the end of 1992, planned an independent assessment on the use of the Certification Scheme in drug procurement and registration systems in order to examine its effectiveness and enhance its wider use.
The assessment took place between April 1993 and February 1994 and involved 15 importing countries from the developing world, two exporting countries and two international supply agencies of low cost essential drugs. Over 40 professionals (12 international team leaders and 30 local team members) participated in the assessment.
The result of the assessment revealed that:
• out of 15 importing countries surveyed, only two use the Certification Scheme as recommended by WHO by requesting a Certificate of Pharmaceutical Product during drug registration. Four countries request a Certificate of Pharmaceutical Product in the procurement of drugs for the public sector. The rest request Free Sale certificates, GMP Certificates and Certificate of Analysis.
• most exporting countries have not standardized the text of their certificates and, therefore, do not issue a Certificate of Pharmaceutical Product as recommended by WHO.
• in one of the two exporting countries surveyed pharmaceutical products for export are not subject to control as are locally consumed pharmaceutical products, while in the second country 152 out of 8200 manufacturers meet the GMP requirements.
Two main reasons accounted for the Scheme not being used as recommended by WHO. These are:
• lack of adequate information on the part of importing countries about the mode of operation of the Scheme, its advantages over and differences from other certificates such as Free Sale certificate, GMP certificate and Certificate of Analysis issued by exporting countries.
• lack of commitment by importing and exporting countries partly due to the voluntary and non binding nature of the Scheme.
Most developing countries still lack their own quality assurance facilities to assess the quality of pharmaceutical products they import. Although the Scheme has certain limitations, if properly used it will allow developing countries to import pharmaceutical products with some degree of quality assurance. Importing countries, therefore, should use the Certification Scheme as recommended by WHO in order to get formal assurance about the registration status and quality of the pharmaceutical products they import. They should also endeavour to set up their own drug regulatory systems based on legislation and regulations, and the WHO Certification Scheme should be a prerequisite in drug registration and procurement. In order to promote effective implementation of the Certification Scheme, importing countries should familiarise registration and procurement personnel with the Certification Scheme through orientation and training programmes.
Exporting countries on their part should standardize the text of their certificate and issue a Certificate of Pharmaceutical Product when requested by importing countries as recommended by WHO. They should also subject pharmaceutical products for export to the same standards of control applied to locally consumed products.
In order to be able to ensure the safety, efficacy and quality of pharmaceutical products they import, WHO should assist developing countries in their efforts to develop their own drug quality assurance systems. The Organization should also embark on a rigorous informational and promotional programme to enable countries to effectively use the Scheme. Such a programme should include regional workshops and seminars that involve representatives from regulatory authorities of both importing and exporting countries. The operation of the Scheme needs to be assessed from time to time in order to evaluate to what extent Member States, importing as well as exporting, are applying the Scheme as recommended by WHO. Moreover, since pharmaceutical product flows in the international market change from time to time, it will be necessary to initiate selected studies as a background for proposals on the use of the Scheme in situations where products are re-exported.