FDA Discusses Progress At ICH4

As the International Conference on Harmonization continues, the drugregulatory agencies of the three ICH regions - the USA, European Union and Japan - are becoming more similar in terms of organization, Roger Williams, deputy center director for pharmaceutical science at the US Food and Drug Administration's Center for Drug Evaluation and Research has told a meeting of the US Food and Drug Law Institute (Marketletter October 13).

ICH issues relate to access, transparency and resources, he said, and while there are various levels of harmonization, the ICH is focusing on guidances for industry.

Japan, the USA and the EU account for 90% of all drugs developed and marketed, but other countries are sensitive about having been excluded, he said; including observers and having a link to the World Health Organization has resolved this somewhat. The ICH was created for issues relating to new molecules, but any decision made will also impact on generics and over-the-counter drugs; the USA cannot have a two-tier quality system, so the ICH agreements had also to be made applicable there for generics and OTCs. Transparency is always a challenge, as is the lack of resources available to carry out the results of ICH work.