2011 Anniversary Yearbook - EUFEPS today and history

that they have reached the conclusion that
great benefit can be derived from ICH.
The ICH meetings take place between
the regulatory and the industrial groups
and those organisations representing
them. But the infrastructure of these
conferences is based on the total scientific
knowledge of the participating regulatory
and industrial experts and academics,
together with R&D findings of clinics
and research centres through the years.
The ICH meetings within the frame work
of science aim at setting and presenting
the regulations within certain limitations.
These should be based on international
and scientific rules. By completion of
inform action and documentation for
presentation to the legal authorities, they
enable rapid supply of pharmaceuticals
to the market and the patient. One should
not lose this perspective in the light of the
volume of data derived from the research
and development of drugs.
Guidelines Produced
The first of the economic problems facing
the research- based pharmaceutical
companies when they develop a new
drug, is the speedy delivery of drugs to
patients and to markets in more countries.
New scientific therapies, approaches
and technologies, on the one hand, have
increased the importance and the impact
of the results and, on the other hand,
have strengthened the relations and the
interaction between scientific R&D
organisations and regulatory authorities.
The fast and linear increase noted in
scientific research, and results in the
second half of the 20th century in
pharmaceutical and medical sciences,
have deemed it imperative that drugs
be speedily dispersed for the health of
the people to other countries besides its
country of origin. Thus when economic
reservations of the companies were
added to the humane, ethical, legal and
medical necessities the harmonisation
activities were brought about. These
tripartite activities between the EU, USA
and Japan are an indispensable step for
strengthening the right to live healthily, by
all the people in the world. There are also
benefits for the world economy, and the
efficient utilisation of human, animal and
substance resources will be achieved with
concomitant increase of quality of life.
For the Benefit of Patients
With the sophistication of technology in the
second half of the 20th century, it is a fact
that the safety standards have increased
the expense of research and development.
But this fact makes it economically
necessary for those companies in vesting
largely in pharmaceutical R&D to expand
their markets to cover the world, instead of
only their own countries. For this reason,
the basic aims of harmonisation are to
set common criteria for the scientific
evaluation of new drugs, to pre vent
unnecessary procedures and duplication
as resulting from different approaches and
methods, to overcome the differing ha bits
and subjectivity of institutions and those
circumstances arising from the customs
and tradition of different countries. In
every ICH meeting for the setting of these
judgement criteria the starting point is
the question. “Is this for the benefit of the
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patient?” With this approach it is going
to be possible for the good quality, safety
and efficacy of drugs to be assured, the
clinical research to be con ducted with
international standards and to harmonise
the work undertaken with advanced
scientific research. A point that should
not be overlooked is that harmonisation
activities undertaken within the scope of
scientific criteria can yield permanent and
realistic benefits, by contrast with work
undertaken with no regard to scientific
criteria.
Effective Pharmaceutical Sciences
The biggest achievement of the ICH has
been that, even though in name it is an
officially tripartite meeting from 1991
up to this day, a harmonisation accepted
internationally, through scientific research
based on detailed work on every level
has been achieved with the participation
of many other countries. Since the talks
held at the conference do not only en tail
the development and the registration of
new drugs in a narrow sense, but also
entail subjects such as informed consent,
protection of patients rights in clinical
research and the use of electronic media
in regulatory communications, which
are all technical subjects based on truths
of science itself, this is a sign that the
harmonisation activities have a broad range
and every chance of being successful.
Doesn’t it warm your heart to see that
pharmaceutical sciences are effective and
a leader with such a universal approach in
the application of human health issues?