The authors discuss the preparedness of European regulatory authorities to implement and enforce the recent EU Directives 2004/27 and 2004/28, which require that all medicines marketed in the EU be made with active pharmaceutical ingredients (APIs) that comply with the harmonized GMP standard ICH/Q7A.
Article / Jul 01, 2006
What Is Next for Suppliers to the European Union?
Pharmaceutical Technology Sourcing and Management, July 2006
Global API Sourcing: What Is Next for Suppliers to the European Union?