(2002; 166 pages)
Regulatory challenges of new technologies
Moderator: Dr John Lim, Singapore
In recent years there has been much research and development in the use of new technologies - such as biotechnology and combination products as therapeutic agents. There are approximately 200 biotechnology products on the market and more than 350 in the late development stage. These products include recombinant peptides and proteins, modified proteins, monoclonal antibodies and related products, gene transfer products, cell-based therapies and engineered tissue products.
Research and development in biotechnology will continue to grow. Regulatory agencies worldwide have a vital role to play in safeguarding public health and in the continued development of such products. Biotechnology products differ from traditional synthetic chemical medicines in several important aspects, including immunogenicity, the inherent greater variability of the manufacturing process, the more limited applicability of animal models, and a greater potential for microbial contamination and the transmission of disease.
The history of clinical use of therapeutic biologicals is extremely short. Sharing and exchange of information between regulatory agencies worldwide will be extremely beneficial in the process of developing new regulations and guidelines. The challenge to both regulators and industry will be to remain vigilant in designing new approaches to risk management and risk communication to ensure the safe use of these products without unduly hampering the development of these exciting technologies.