Correction: WHO Generic Guide

A report in the Marketletter April 10, incorrectly stated that the World Health Organization's new guide on generics had been discussed by the Steering Committee of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), held in Washington DC, USA, at the end of last month.

In fact, the press release from WHO associate director Juhana Idanpaan-Heikkila on WHO's progress report on global harmonization (which on a covering sheet indicated that the matter had been discussed at the ICH Steering Committee meeting March 27-30) stated that a Guideline on Registration Requirements to Establish Interchangeability of Multi-Source (Generic) Pharmaceutical Products has been adopted by the WHO Expert Committee.

This guideline was discussed at three consultations held in Geneva in 1993 and 1994, and with representation from a number of drug regulators, academia and the pharmaceutical industry. The draft was subsequently distributed to WHO member states and industry. It was neither discussed or adopted by the ICH Steering Committee.