Drugs are of critical value to human health and well-being and thus play a central role in any health care system. But their potential can only be realized if they are accessible, used correctly and of acceptable quality. They can be dangerous if control over their manufacture, storage, distribution, supply, sale and use does not meet required standards.
During recent decades many pharmaceutical industries and distribution channels have flourished, leading to the proliferation of products on national and international markets. This situation has strained the capacity of regulatory authorities, particularly in developing countries. Many of them find controlling not only the quality but also the promotion and use of drugs to be difficult. This inability to exercise adequate control is reflected in the prevalence of substandard and counterfeit drugs, and weaknesses in quality assurance. The latter have sometimes resulted in the deaths of hundreds of people. Additionally, scientific and technological progress, and liberalization of world trade, will also have profound effects on the manufacture, distribution and sale of drugs. Countries must take action now to strengthen their regulatory capacity and their ability to react effectively to changing conditions.
In those developing countries where drug regulation is weakest, priority should be given to assessing the existing regulatory situation, and identifying weaknesses and the reasons for them. Additionally, these countries should identify priority activities and establish a regulatory system, taking into account local conditions and the resources available.
At an international level, new trade agreements will require the application of international standards to ensure the quality of pharmaceutical and biological products. Effective control will require adequate control facilities and technically competent staff.