(2002; 166 pages)
Regulating biotechnology products
Moderators: Dr Lucky S. Slamet, Indonesia, Mr Mark A. Elengold, USA
Biotechnology, including DNA technology, has opened up new and promising opportunities for the diagnosis, prevention and treatment of diseases through, for example, the provision of safe and effective drugs and vaccines, as well as sensitive diagnostic tools. However, the use of these biological substances raises concerns about safety and quality, resulting mainly from the novel processes used in manufacture and the complex structural and biological characteristics of the products themselves. It is therefore important to ensure that control measures are in place to ensure the quality of the manufacturing process and of its products and to safeguard recipients against possible adverse events.
This session looked at balancing the risks and benefits of biotechnology products through regulation based on international or global standards and norms, while not limiting development or use. Regulation that is comprehensive but simple to implement is particularly important for developing countries, where the technological base is limited and expertise may be less specific. Issues related to the comparability of biotechnology products, including those related to scale-up, were highlighted as needing particular attention.