The WHO Expert Committee on Biological Standardization met in
Geneva from 26 to 30 November 2001. The meeting was opened on
behalf of the Director-General by Dr Yasuhiro Suzuki, Executive
Director of the Health Technology and Pharmaceuticals cluster.
Dr Suzuki noted that the past 2–3 years had been a time of considerable
change and strengthening for the work on biologicals at WHO.
This had been in response both to the general restructuring of WHO
under the leadership of the Director-General, and to the resolution
on the quality of biological products moving in international commerce
(WHA 50.20), unanimously adopted by the World Health
Assembly in 1997, and the subsequent report of the independent
review of the remit and activities of WHO in the biologicals field and
of the biologicals unit, which was submitted to WHO in November
1998. As a consequence, substantially more resources had been secured
for work on the standardization and control of biological
medicines during 2000 and 2001. Staffing levels had risen significantly,
and had included a high-level secondment for 2 years from the Korea
Food and Drug Administration, for which the Organization expressed
gratitude to the Government of the Republic of South Korea,
and significantly more funding was available for biological standardization
activities. Nevertheless, more effort was needed to reach an
appropriate level of funding and staffing for WHO’s work in the
biologicals field, which is undertaken by the Quality Assurance and
Safety of Biologicals (QSB) and Quality Assurance and Safety of
Plasma Derivatives and Related Substances (QSD) units working
together even though managerially they were placed in different
departments. There was also increasing interaction between the
biologicals team and other groups in WHO.