Dr Moustapha EI-Hadary, Egypt

Egypt now counts some 6o million inhabitants with a population growth rate of 2%, while 37% of the population is below 15 years of age. The pharmaceutical industry is made up of 32 manufacturers, of which 12 are multinational companies. Annual growth is now at 14% and products are approved through a registration system based on a reference list of 18 countries, the majority of which are members of ICH.

Developing countries understand that the ICH guidelines can be of value in the development of new drug substances. However, the needs of developing countries are for simpler guidelines which are focused on generic products to meet basic requirements. Furthermore, in order to understand the implications of the ICH guidelines we need to improve our professional knowledge to include the highly complex techniques which are described in the guidelines. At the moment, WHO is of particular support to developing countries because the Organization provides guidelines which cover generic/ multi-source products. On the other hand, the ICH guidelines are of great use to pharmaceutical companies, whereas we would prefer guidelines which give comprehensive guidance on the quality, safety and quality from a regulatory point of view. As an example, ICH guidelines should also cover stability testing for all climatic zones throughout the world.

It is also unfortunate that regulatory authorities in developing countries do not have the time and resources to be able to comment on the draft guidelines, which are very extensive and technical in content. Developing countries would appreciate the opportunity of being included in the ICH process and decisions affecting them.

There are undoubtedly many positive aspects to the ICH process. Harmonization on global and regional levels will no doubt enhance the quality of pharmaceuticals which will, in turn, provide better access. Also, the elimination of redundancy and duplication of technical requirements is seen as very positive. We hope that a consensus can be reached concerning administrative requirements and labelling of products. Overall, non-ICH countries are keen to play an active role in the process in order to minimize the gap between developed and developing country regulations. WHO is requested to provide information and educational activities concerning the ICH process and its repercussions for developing countries.