E-drug: ICH and developing countries
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dear E-druggers,
The International Conference on Harmonisation (ICH; see webpage
http://www.ifpma.org/ich1.html) has been discussing harmonised
guidelines for the last ten years on efficacy, safety and quality of
medicines.
ICH comprises 17 countries (USA, EU, Japan) which control the
majority of the world's drug production. Although developing
countries are free to attend ICH meetings, they are not part of the
decision making process. WHO and some other countries are observers.
Some people fear that the high quality standards (e.g., impurities in
raw materials) will make drug production in developing countries much
more expensive.
Other people have remarked that consumers / patients have not been
involved in the development of Good Clinical Practice guidelines
which define ethical standards for testing drugs on humans etc.
Can we start a discussion on the relevance and applicability of ICH
guidelines for developing countries on E-drug?
Does someone know of published reviews of the ICH process from a
developing country or consumer perspective?
kind regards
Wilbert Bannenberg
co-moderator E-drug
Email: WilbertBannenberg@compuserve.com
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