Chemistry Reference
In-Depth Information
Brussels. Since this first organizational meeting, a biennial conference has been held,
in addition to other periodic conferences and workshops.
Initially, a threefold purpose (“Terms of Reference”) was identified:
1. To provide a forum for discussion between regulatory agencies and the
pharmaceutical industry on the differences in the technical requirements
for product registration in the three member regions
2. To identify areas where changes in technical requirements and agreement on
research and development procedures could lead to a more economical use
of resources (human, animal, and material) without compromising safety
3. To recommend practical ways to achieve harmonization in the interpreta-
tion and application of technical guidelines
These original terms of reference have since been modified, however:
1. To maintain a forum for a constructive dialogue between regulatory author-
ities and the pharmaceutical industry on the real and perceived differences
in the technical requirements for product registration in the EU, the United
States, and Japan in order to ensure a more timely introduction of new
medicinal products, and their availability to patients
2. To monitor and update harmonized technical requirements leading to a
greater mutual acceptance of research and development data
3. To avoid divergent future requirements through harmonization of selected
topics needed as a result of therapeutic advances and the development of
new technologies for the production of medicinal products
4. To facilitate the adoption of new or improved technical research and devel-
opment approaches that update or replace current practices, where these
permit a more economical use of human, animal, and material resources,
without compromising safety
5. To facilitate the dissemination and communication of information on har-
monized guidelines and their use such as to encourage the implementation
and integration of common standards
The term
ICH
, while originally was meant to denote an international conference on
harmonization, has now become more associated with the
process
of harmonization
than the actual conferences themselves. Indeed, many of the recommendations or
guidelines developed as a result of the ICH processes have been implemented; how-
ever, more are forthcoming.
1.4.1 S
tructure
of
the
Ich
At the inaugural meeting of the ICH, representatives of the regulatory agencies
and industry associations of Europe, Japan, and the United States met to establish
terms of reference, and created a steering committee that has since met at least twice
yearly. These six founding parties (three regulatory and three trade associations) are
the direct participants in the ICH process.
