International trade in pharmaceuticals increased to the extent that the dangers posed by poor quality drugs in international commerce, particularly those destined for markets in developing countries, became a concern, particularly among consumers. Following the establishment of WHO in 1948, this concern received international recognition.
WHO undertook a number of initiatives to improve drug quality in its Member States and to promote global mechanisms for regulating the quality of pharmaceutical products in international markets. These included:
• selection of international nonproprietary names for pharmaceutical substances;
• publication of the International Pharmacopoeia;
• establishment of WHO GMP guidelines for pharmaceutical products;
• creation of WHO Certification Scheme to ensure the quality of pharmaceutical products sold on international markets;
• creation of national and regional quality control laboratories.
These and other global norms, standards and guidelines developed by the Organization contributed to the improvement of drug regulation at country and global levels. With the establishment of the WHO Action Programme on Essential Drugs (DAP) in 1981, the need for providing guidance to developing countries to improve their regulatory system received more attention. At the same time, many more standards and guidelines dealing with regulatory and quality assurance issues were developed by WHO and made available to countries.
The Conference of Experts on the Rational Use of Drugs, held in Nairobi in 1985, underlined the need for developing countries to strengthen their drug regulatory system based on sound drug legislation.10 This was further emphasized in WHO’S revised drug strategy in 1986.11
Post-Nairobi developments reinforced the need for WHO to continue its activities to sensitize countries to revise and update national drug legislation and to provide assistance within its mandate and competence to strengthen national drug regulation.
With respect to developing countries, WHO has been providing support in the setting up and strengthening of drug regulatory and quality assurance systems. For instance, between 1983 and 1997, it helped around 70 countries to either enact new drug legislation, or to amend existing drug legislation.12
In the past two decades, efforts have also been made to foster closer cooperation between the drug regulatory authorities of developing countries. In 1982, WHO catalysed technical cooperation among the developing South-East Asian countries (ASEAN/TCDC), together with the United Nations Development Programme, in the area of quality assurance. The cooperation has served as a vehicle for developing regulatory standards, norms and guidelines, as well as for the transfer of knowledge and skills in drug regulation between Member States. The creation of drug regulatory authority networks, such as the International Conference of Drug Regulatory Authorities, the Eastern Mediterranean Countries Drug Regulatory Agencies Conference and the African Drug Regulatory Authorities Network, has also been instrumental in promoting closer cooperation between national drug regulatory authorities to discuss issues of mutual interest and facilitate timely exchange of technical information.
At the same time, geopolitical groups in Asia, Europe and Latin America have promoted the harmonization and mutual recognition of drug regulation at regional, subregional and global level, facilitating technology transfer and trade in pharmaceuticals.