18 Racial and Ethnic Issues

in Drug Registration

LionelD.Edwards,J.M.Husson,E.Labbe ́,C.Naito,M.PapalucaAmati,

S. Walker, R. WilliamsandH. Yasurhara

18.1 Background

The international need for quicker national
approval of significant drugs offering improved
therapy, less toxic effects and even cure had been
delayed and restricted by differing mandatory reg-
ulatory requirements between nations. Thus, by
1980, the need for an international cohesive policy
was apparent. Discussions between the regulatory
authorities of Europe [European Medical Evalua-
tion Agency (EMEA)] and the United States (FDA)
were aimed at the harmonization of regulations
governing the approval process of drugs and
devices and have been going on since the first
International Conference of drug regulatory autho-
rities, which met in October 1980 (Annapolis,
USA), and latter under the auspices of the Interna-
tional Conference on Harmonization (ICH). In
their first meeting in Brussels (November 1991),
the Japanese regulatory authorities [Ministry of
Health and Welfare (MHW)] participated as a
full member; these three major regional members
were joined by representatives from the pharma-
ceutical industry of Japan (JPMA), Europe
(IFHPA) and United States (PhRMA) and obser-
vers from the World Health Organization (WHO)
Nordic countries and Canada’s HPB, thus covering

about 92% of the current regulatory activity and

global spending on pharmaceuticals.

The ICH continuing series of meetings has

resulted in success in the areas of quality control,

toxicology, pharmacology and clinical development,

including good clinical practice(GCP) and the recent

issue of guidances on the acceptability of foreign

clinical data, the Common Technical Document,

adoption of MeDRA and electronic submissions.

The clinical area has proved much harder to

harmonize because of the lack of clear-cut regional

or national concordance on many clinical issues.

The very existence of some diseases is in dispute,

for example, temporomandibular joint dysfunction

and premenstrual syndromes in the United States,

hypotension syndrome (Pemberton, 1989) in

Europe, and ‘heavy leg’ pre-varicose vein syn-

drome in Switzerland. The emphasis on treatment,

overprevention and the real physical and genetic

differences between national populations with

variety of healthcare systems can cause disparity

of results, observations and conclusions. Again,

diversity within a national population, geographic

influences, diet, varied measurement standards,

religious and cultural effects, and patient–doctor

relationships also play a part in making interpreta-

tion and agreement difficult.

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9