WHO plays a major role in promoting and facilitating the transfer of appropriate laboratory science into the clinic and in assuring the subsequent quality, safety and efficacy of biological medicines, as well as the reliability of diagnostic tests. This is done by developing internationally-agreed written and physical standards and in encouraging the global exchange of experiences with biologicals. The work is undertaken by WHO's Biologicals Unit (BLG) within the Division of Drug Management & Policies and its Expert Committee on Biological Standardization and texts are developed for the guidance of national health authorities on the production and control of specific biologicals. The Committee also establishes WHO international reference materials against which batches of research materials or manufacturers' products can be assessed. Examples of WHO requirements and guidelines on relevant biotechnology-derived biologicals are set out in the table overleaf.
Biological substances used in medicine make a vital contribution to public health. However, the nature of biologicals raises particular questions regarding their regulation, and the considerable potential hazards associated with some of these substances need continuous vigilance. The field of biologicals is one of expansion and increasing diversity, especially in the area of biotechnology. The revolution in DNA-based and related cell technologies has opened up a new and exciting vista for global health care. In some instances, traditional products are being replaced by equivalents derived by recombinant DNA technology. New possibilities for diagnostics are emerging, such as the use of gene amplification methods for the virological safety testing of blood and blood products, and there are exciting new approaches to vaccination through the use of DNA-vaccines.
New biotechnology-based medicines and diagnostics need to be incorporated into the health-care systems of all countries, as appropriate, and mechanisms need to be in place to assure that new products, such as vaccines, are made available to all who need them. Although many recent developments, such as gene therapy and DNA-vaccines, have taken place primarily in developed countries, the biotechnology industry is evolving rapidly in an increasing number of developing countries and it is important that these activities be supported and strengthened. One vital need is for respected worldwide standards of quality for biotechnology products. Adequate control measures are essential both to safeguard recipients of these products against adverse effects and to ensure that the full benefits of scientific innovation are widely available to those who need them most. The early availability of guidelines on the production and quality control of biotechnology-derived medicinal products, particularly in Europe and the United States, has been instrumental in establishing the quality, safety and efficacy of recombinant DNA-derived products and these guidelines are providing the framework for moving forward with new biotechnologies. A well balanced, sound scientific approach to regulating novel technologies is essential and the challenge is in ensuring public safety, whilst at the same time not inhibiting the development of new technologies which may have enormous benefits for public health. It is of paramount importance to all parties involved in these developments - manufacturers, regulators and the public - that regulatory guidance, the provision of standards, and the design of appropriate in-process tests keep pace with advances in science.
Decisions on regulation and testing of biologicals and biotechnology products increasingly need to be made internationally for several reasons, such as for global public health, global trade and for the efficient use of national regulatory resources. Ways of improving and coordinating collaboration between national, regional and international agencies, and especially of supporting developing countries, need to be explored, as do the ways in which WHO can best promote such cooperation.
WHO REQUIREMENTS AND GUIDELINES
Requirements for hepatitis B vaccines made by recombinant DNA technologies. WHO Technical Report Series No. 786, (1989)
Guidelines for assuring the quality of pharmaceutical and biological products prepared from recombinant DNA technology. WHO Technical Report Series No. 814, (1991)
Guidelines for assuring the quality of monoclonal antibodies for use in humans. WHO Technical Report Series No. 822 (1991).
Good Manufacturing Practices for biological products. WHO Technical Report Series No. 822 (1992).
Guidelines for national authorities on quality assurance for biological products. WHO Technical Report Series No. 822 (1992).
Regulation and licensing of biological products in countries with new developing regulatory authorities. WHO Technical Report Series No. 858 (1995).
Requirements for the use of animal cells as in vitro substances for the production of biologicals.
Guidelines for assuring the quality of DNA-vaccines.
Guidelines for the production and control of on acellular pertussis component of monovalent or combined vaccines.