38 Drug Labeling

Anthony W. Fox

38.1 Introduction

The purpose of the drug label is stated succinctly in
the Japanese guidelines:

Package insert statements should generally contain

information essential to using the specified drug for

approved indications and within the range of

approved dosage and [route of] administration. How-

ever, other important data regarding any use of the

drug should also be evaluated and described. (PAB

Notification No. 606, 25 April 1997)

In other words, the drug label is the summary of all
that is learned during drug development plus that
which is inevitably discovered during post-
marketing surveillance. The terms ‘drug label’
and ‘package insert’ (the former in common use
in North America, the latter in Europe and Japan)
are used interchangeably in this chapter.
The intent of this chapter is to review drug
labels in North America, Europe and Japan. The
philosophy of these differing types of labeling
will be explored. The reader can easily access
local examples of current, approved labeling;
these will not be reproduced here, and could, in
any case, become rapidly out of date. Much of the
content of drug labelingis the subject of other

chapters in this book, the approach here will

avoid redundancy.

38.2 Drug labeling in Japan

1

The Ministry of Health and Welfare has a subordi-

nate organization known as the Pharmaceutical and

Medical Safety Bureau, which supervises drug

labeling in Japan. This bureau has prescribed a

standard set of subtitles for drug labeling which

must always appear (Table 38.1).

As can be seen, the structure of a Japanese drug

label is a standard format that would also be famil-

iar to physicians in Europe or North America.

The one major difference, however, is that a

separate regulation (PAB Notification No. 607,

25 April 1997) governs how precautions should

be displayed in drug labels, and is quite elaborate

in comparison to European or North American

counterparts. The Warnings and Contraindications

sections of the drug label (items 6 and 7 in

Table 38.1) are required to contain, under this

regulation, the following subsections (Table 38.2).

Although most of these subtopics (Table 38.2)

would have stand-alone counterparts in drug

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

(^1) Acknowledgment to Dr Hiroko Sakai, Yamanouchi Pharma-
ceuticals, Tokyo, Japan.