Euro Commission, EMEA Consider Global Dossier

Looking 10 years ahead, European pharmaceutical regulators meeting at the European Medicines Evaluation Agency in London last week forecast the existence of guidelines for a common global drug registration dossier, but no global registration agency.

The Fourth International Conference on Harmonization (ICH IV) will be held in Brussels on July 16-18, 1997, and EMEA director-general Fernand Sauer said agreement over the rules of the game for a single dossier, under discussion since 1991 will probably, to a large extent, be complete then. He foresaw eventual joint assessments between the ICH partners (USA, European Union and Japan), but said a single global agency would raise problems of sovereignty, and recommended making the best of harmonization.

Noting the changes since ICH I in November 1991, Mr Sauer said the industry is now working with regulators, who are in turn, for the first time, involved in international dialogue, rather than ignoring each other and conducting their affairs privately as they did in the past, when harmonization had simply meant lining up with the Food and Drug Administration.