Stepping up the pace: agency bosses take control in fight to keep global pharma supply chain safe

摘要

Some of these programs reflect leadership and expertise in standards development and the harmonization of good regulatory practices, Dr Hamburg said.The development of science-based standards and harmonized practices and approaches is "an essential underpinning of any strategic direction by regulators", she added, and so some of the mechanisms "can be effective operational components and connectors in the implementation of any global coalition's strategic direction".For Mr Kalis, the fact that ICMRA will operate at the executive level is critical. With ICH, for example, a lot has been achieved since it was set up at the end of the 1980s, he says. However, the pace at which changes are being implemented at the moment is "not too fast". A reason for this, Mr Kalis suggests, is that the initiative works at an operational level. "You are always in a negotiating position, you can never take a decision, you have to go back to your boss" for further discussion.