[e-drug] The impact of applicability of ICH guidelines in developing

[abenfeddoul@hotmail.com]

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E-drug: The impact of applicability of ICH guidelines in developing countries ?
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The impact of applicability of ICH guidelines in developing countries ?

The ICH ( International Conference on Harmonization) initiative, which
started in 1990, includes drug regulatory authorities of the European 
Union (European Agency for the Evaluation of Medicinal 
Products,EMEA), Japan (Ministry of Health, Labour and Welfare, 
JMHLW), and USA ( Food and Drug Administration, US FDA), assisted by 
the research-based pharmaceutical industry associations of those 
countries: the European Federation of
Pharmaceutical Industries Associations EFPIA, the Japan 
Pharmaceutical Manufacturers Association JPMA, and the Pharmaceutical 
Research and Manufacturers of America PhRMA. The International 
Federation of Pharmaceutical Manufacturers Associations IFPMA acts as 
the secretariat of ICH. WHO, Canada and the European Free Trade Area 
EFTA have observer status in ICH activities.

ICH is administered by the ICH Steering Committee which is supported by the
ICH Secretariat.

Since ICH was established, each of the six co-sponsors has had two 
seats on the ICH Steering Committee (SC) which oversees the 
harmonization activities. The Observers, WHO, Health Canada, and the 
EFTA, nominate participants to attend the ICH SC meetings.

The objective of ICH is to increase international harmonization of 
technical requirements to ensure that safe, effective, and high 
quality medicines are developed and registered in the most efficient 
and cost-effective manner.

There were five meetings: ICH1 in Brussels (Belgium)in 1991 , ICH2 in
Orlando (USA) in 1993 , ICH3 in Yokohama (Japan) in 1995, ICH4 in 
Brussels in 1997 and ICH5 in San Diego (USA) in the year 2000.  ICH6 
will be a meeting held in July 2003, in Japan.

Since 1990,the International Conference on Harmonisation finalized 
more than 45 guidelines with regard to quality, safety, efficiency 
and even communication (the last one is that of the electronic Common 
Technical Document eCTD).

The ICH can be considered as a success for the international 
cooperation in medicine. But who benefits well from this cooperation?

The big pharmaceutical firms which represent about 80 % of the world
production can easily apply ICH standards to market their products 
and to develop other molecules.  However, the small structures and 
the pharmaceutical industry of developing countries will have 
difficultyin meeting the extreme standards, because their application 
demands high costs.

Even if the manufacturers of these countries quickly respect those norms, most
of them would not be able to follow and we would have an even more 
imperious position of strong multinationals with their economic power.

The local production of these countries, for lack of means and 
technology, will thus be in deficit with regard to the ICH standards 
in terms of quality, efficiency and safety. Medicines produced so 
will simply be considered as counterfeit or defective. It was 
recommended in a report published in March 2002, that the WHO should 
establish a mechanism to review and build on ICH guidelines in order 
to produce WHO guidelines.

The population of developing countries needs local production and 
traditional medicines to face a difficult sanitary situation. The WHO 
should find a compromise between the continuance of this local 
production and the assurance of the quality of medicines produced in 
order to build a series of standards based on minimal requirements to 
ensure quality, efficiency and safety(security).

The ICH could contribute on the other hand to improving the quality of
medicines imported by the developed countries if it manages to 
harmonize the practices of the export of medicines by adopting 
standards to guarantee a quality especially towards the countries 
where the absence of laboratory control does not allow them to check 
good quality.

I am interested to know the opinions of the concerned persons and 
with the aim of
writing a thesis on the subject, I thank you for answering some questions.

Adib BENFEDDOUL
Chemist Bordeaux France
abenfeddoul@hotmail.com


[Adib BENFEDDOUL has prepared a questionnaire.  If you are interested 
to help him by completing the questionnaire or with further 
information please contact him directly:  abenfeddoul@hotmail.com. BS 
moderator]



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