Annex 1
ABPI EVIDENCE TO THE HOUSE OF COMMONS SCIENCE
AND TECHNOLOGY SELECT COMMITTEE INQUIRY INTO CANCER RESEARCH
Trevor Jones has asked me to write to you on
behalf of the ABPI following your concerns over our evidence to
the Science and Technology Select Committee inquiry into Cancer
Research. I enclose a copy of the relevant section[21].
As you will see this relates to the differences in audit and data
collection requirements as laid out in your guidelines compared
to those of the International Conference on Harmonisation (ICH).
This difference is important when an MRC trial might lead to an
application for a marketing authorisation or an indication extension
of a medicine. Although the ICH GCP guidelines are guidelines,
the regulatory authorities do tend to require clinical trials
supporting an application for a marketing authorisation to be
done to ICH guidelines.
I hope this clarifies the statement. It is important
that both NHS R&D and/or MRC studies done in collaboration
with the pharmaceutical industry are done to the standard required
for obtaining a marketing authorisation for a medicine.
Dr Richard Tiner
Medical Director
7 April 2000
21 Annex 2. Back
| 
