ヨーク会議報告で述べたような経過で、WG15の性格が以下のように決まりました。
その活動の第１のステップとして、前臨床生物試験の国際調和に関する課題を抽出し、
優先順位を決めて具体化の道をさぐることにしました。
以下は、ヨーク会議で抽出された課題の例ですが、他にも諸々あると思われます。
どなたでも、どんな意見でもお聞かせ下さい。
意見提出先：中村晃忠
国立衛生試験所
ＦＡＸ：０３−３７０７−６９５０
Ｅ−ｍａｉｌ：ｎａｋａｍｕｒａ＠ｎｉｈｓ．ｇｏ．ｊｐ
OBJECTIVES OF ISO TC194/WG15 "Strategic Approach to Biological Assessement"
Promote internationally uniform application of the standards for preclinical
biological safety assessment per product group, by manufacturers, authorities
and third parties, in order to minimize the amount of testing needed, and
optimize the biological safety evaluation, by ensuring:
# a common understanding of the biological risk evaluation and management
procedure;
# application of tests;
# inclusion of relevant tests;
# differentiation of product type/categories related to the risk evaluation
procedure.
WG15 will provide guidance and advice to TC194. For the time being, WG15
will not elaborate a standard.
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At first listing of questions and issues to be addressed:
Category 1: Needs for standards resulting from environment such as regulatory
or market issues:
# common biological risk evaluation and decision procedure;
# how are devices categorized in different regions with the consequences
for the evaluation procedure (who requires, who submits, who reviews,
who recommends, who approves);
# other concepts usable for selection or deletion of test (e.g., material
dependent, device size dependent, etc.);
# how to get input on practical experience on the suitability of the
standards;
# new items from different regions (e.g., immunotoxicity);
# the amount of data needed for decision (minimum for safety / all data /
additional data) and use of data and experience from comparable products;
Category 2: Set of standards (contents and consistency of standards)
# new subjects and tests (e.g., particles and antigenicity);
# expansion of applicability of test (methods → bioresorbables);
# long term effects of implants;
Category 3: Practical aspects resulting from application of standards
# risk evaluation procedure: e.g.,
# in vitro / in vivo correlation
# sensitization evaluation
# genotoxicity evaluation
# qualification of experts;
# training of experts
# understanding product and use;
# understanding responsibilities;
# understanding biological evaluation and its
relevance to application of the product;
# definition of test and interpretation of test results
# availability and use of database
# test protocols: sufficient flexibility and standardized where appropriate
and necessity;
# feedback of practical experience from use.
(This listing is non conclusive and will be updated continuously).