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Over the past twelve years, the Centre for Medicines Research has
held a series of Workshops on a number of topics related to the
drug discovery and development process. The major objective of
these Workshops has been to provide an international forum for
regula tory, academic and industry representatives to debate
together, and suggest solutions to, specific problems. The meeting
reported in this volume represents a departure from this approach,
in that the par ticipants were drawn largely from the
pharmaceutical industry. Senior clinicians, pharmacologists and
toxicologists from companies in Europe, the USA and Japan met in
May 1994 to discuss a scientific rationale for the conduct of
toxicity studies to support the clinical development of new
medicines, and to begin to work towards an industry consensus.
Achievement of such a consensus is seen as an important step in the
process leading towards international harmon isation of the
recommendations on the timing of toxicity studies in relation to
clinical trials."
At a time when it is becoming usual for medicines to be developed
for a global market and pharmaceutical companies are endeavouring
to expedite the drug development process, Regulatory Authorities
are concentrating on improving their efficiency and effectiveness.
Therefore, it is not surprising that questions are being asked as
to how performance might be measured and compared between different
authorities who are now often in receipt of dossiers that have been
submitted to several agencies at the same time. Issues such as
'what target should be set for the review of new medicines?' and
`how can quality be assured?' are now considered to be of critical
importance. The twelfth CMR International Workshop, held in January
1997, provided the opportunity for Regulatory Authority and
industry personnel from Europe, North America, Australia and Japan
to openly discuss experiences and exchange views on how to improve
the review process. The proceedings of this meeting provide a
comprehensive overview of the current review process in different
countries and the need for performance measures and targets. This
volume summarises the many suggestions that were debated at the
Workshop, and includes chapters on measuring performance, and on
the integration of quality into the review process.
For a research-based pharmaceutical company to be successful in the
1990s. it must have a strategic plan for the global development of
new chemical entities. Global development can be defined as an
attempt to reach all major markets as rapidly as possible and for
many companies these will include the United States. Japan.
Germany. France. Italy. UK and Canada. which together represent
approximately 85% of the pharmaceutical market in the developed
world. The mutual acceptance of foreign clinical data would reduce
the time and resources required to develop a new medicine for the
international market by eliminating the requirement for the routine
repetition of clinical studies in local populations. In Japan this
has been largely based on the belief that genetic differences in
respon siveness may result in a different benefit/risk assessment
for a new mediCine. while requests in Europe and the United States
for local data relate mainly to methodological and cultural
considerations. The importance of this issue has been recognised
internationally as it was one of the topics discussed at the
International Conference on Harmonisation in Orlando (October 1993)
and it is currently on the programme for ICH3 which will be
convened in Yokohama in Japan in November 1995."
Over the past twelve years, the Centre for Medicines Research has
held a series of Workshops on a number of topics related to the
drug discovery and development process. The major objective of
these Workshops has been to provide an international forum for
regula tory, academic and industry representatives to debate
together, and suggest solutions to, specific problems. The meeting
reported in this volume represents a departure from this approach,
in that the par ticipants were drawn largely from the
pharmaceutical industry. Senior clinicians, pharmacologists and
toxicologists from companies in Europe, the USA and Japan met in
May 1994 to discuss a scientific rationale for the conduct of
toxicity studies to support the clinical development of new
medicines, and to begin to work towards an industry consensus.
Achievement of such a consensus is seen as an important step in the
process leading towards international harmon isation of the
recommendations on the timing of toxicity studies in relation to
clinical trials."
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