free movement of goods within the EC, that is an
industrial/commercial objective. In the future, it
might be more logical for the functions of EMEA
to be the responsibility the Health Directorate
rather than the Enterprise Directorate.
The CPMP and European harmonization
of data requirements and ICH
It might not be immediately apparent that the
drive toward ‘harmonization’ of regulatory
requirements had its birth at the first meeting of
the CPMP in November 1976. The CPMP at that
juncture had been established to operate a ‘mutual
recognition’ procedure, laid out in Directive 75/
318, but it had no work to do initially. It was,
however, immediately clear to the CPMP that the
data requirements laid down for registration were
being interpreted differently by individual mem-
ber states’ regulatory authorities. For example,
there was no agreement on requirements for repro-
duction studies, carcinogenicity, studies and so on.
At that first meeting, two expert working groups on
safety and efficacy were established to draw up
guidelines (later, other expert working groups
were established). A great deal of international
harmonization of requirements and thought was
achieved,andthiscouldclearlybeextendedbeyond
the confines of the EC.
By June 1984, the EC Commission decided
that a meeting with the Japanese authorities,
attended by Mr Fernand Sauer and the Chairmen
of the Safety and Efficacy Groups J.P. Griffin and
J.M. Alexander should take place in Tokyo. As a
result of this, a second meeting with the Japanese
authorities (the JPMA), the EC Commission and
EFPIA representatives took place. This was the
stimulus for EFPIA, JPMA and the PMA, as it
then was in the United States, to press for wider
consultation. From such a start, the International
Conference on Harmonization (ICH) was born.
The ICH Steering Committee established expert
working groups (EWG) to discuss areas where
harmonization was possible and to produce uni-
versally acceptable guidelines. Thus, under the
auspices of the ICH, a considerable number of
guidelines have been issued in the areas of qual-
ity, safety and efficacy, with the objective of
achieving harmonization of requirements for
registration between regulatory authorities, and
thus reducing the need for duplicating studies. It
must be made clear that these documents should
be regarded as guidelines, not requirements.
These guidelines are not at the cutting edge of
science but represent acceptable compromises.
Guidelines will need updating, and this must be
coordinated, otherwise there will be ‘regulatory
drift’ toward disharmony.
If harmonization can be achieved, as it has been,
across sufficiently broad areas of quality, safety
and efficacy, there is no logical reason why a com-
mon technical document (CTD) or dossier cannot
be prepared that would be acceptable to all drug
regulatory authorities. Movement to a CTD would
appear to be the next step toward further interna-
tionalization.
The ICH guidelines and details of their evo-
lution can be obtained in the Proceedings of the
First, Second, Third and Fourth International
Conferences on Harmonization, held in Brussels
(1991), Orlando, USA (1993), Yokohama, Japan
(1995) and Brussels (1997), published by the
Queen’s University of Belfast and obtainableTable 33.10 Mutual recognition procedure and Arbitrations for 1999Mutual recognition Total submitted Under evaluation Ended positively Arbitrations
procedure in 1999a in 1999 in 1999 in 1999
New applications 275 48 210 2
Type I variations 695 90 625 0
Type II variations 254 109 292 2
aThe number includes multiple procedures.438 CH33 THE DEVELOPMENT OF HUMAN MEDICINES CONTROL IN EUROPE