(2002; 166 pages)
The need to make optimal use of the products of new biotechnologies in the prevention, diagnosis and treatment of diseases that are the major causes of morbidity and mortality throughout the world, especially in developing countries, was recognized. However, it was emphasized that these are highly complex products, often manufactured using novel biotechnologies, and the need for careful evaluation and regulation was vital. Issues relating to the comparability of biotechnology products, including those of scale-up, were highlighted as needing particular attention.
Rapid growth of the biotechnology industry in a number of developing countries was noted, as was the science-based regulatory oversight already in place in some instances. However, effective regulatory oversight, as well as adequate resources to deal with biotechnology products, was still needed in the majority of developing countries. Full support was expressed for the application of biotechnology to the development of vaccines, therapeutic biologicals and diagnostics for the prevention, treatment or diagnosis of disease.
1. Given the rapid advances in biotechnology and the challenge of balancing the risks and benefits, WHO, in collaboration with regulatory authorities, should monitor developments and continue to provide clear guidelines on issues relating to quality, safety and efficacy of biotechnology-derived medicinal products, including biocomparability. Rapid dissemination of this advice is crucial and WHO should strive to improve awareness of available guidance.
2. Regulatory authorities lacking experience in the regulation of biotechnology-derived products should be strengthened through education, training and updating, as appropriate. They should draw upon the knowledge and skills of regulatory authorities already experienced in this area, with the collaboration of WHO. Regulatory authorities should recognize the need to support the participation of officials at scientific and related meetings dealing with the regulation of this fast-developing field.
3. Regulatory authorities with limited experience should identify sources of expertise within their countries, such as in academia, to assist in the review of applications for clinical trials and for marketing authorizations. Where these are lacking, the support of experts from more experienced regulatory authorities should be explored, with the assistance of WHO, as a means of obtaining the necessary skills and knowledge.
4. WHO should continue development of International biological reference materials that can serve as reference standards for new products.
5. Progress should be reported back to the ICDRA.