(2003; 148 pages)
2.8 International Conference on Harmonisation (ICH)
The Committee was provided with a draft document titled “Some considerations on the impact of ICH in non-member countries” and the Committee was informed that this document and its recommendations would be brought to the attention of the Tenth International Conference of Drug Regulatory Authorities to be held in Hong Kong Special Administrative Region of China in 2002.
The Committee considered that, while ICH standards were important in specifying requirements for pharmaceutical manufacturers of new chemical entities, WHO had an important role in adopting and adapting ICH standards for developing countries. The Committee therefore endorsed the need for WHO to intensify its efforts to develop international standards on the approval of generic products in consultation with the generic industry, related organizations and national authorities. This would improve access to quality essential drugs.
The Committee endorsed the general principles of the document.