The European Fine Chemicals Group (EFCG) has proposed a standardized set of global rules and regulations governing the production of active pharmaceutical ingredients.
The standards would level the worldwide playing field to ensure the quality of active pharmaceutical ingredients, or APIs, and medicines containing them meet the high standard recognized by developed economies.
EFCG expects this to be achieved via mandatory inspections of all global API manufacturers through a mutual recognition agreement approach and managed by the National Regulatory authorities to share scarce inspection resources and avoid the present duplication.
EFCG says it believes the new Falsified Medicines Directive (2011/62/EU) designed to minimize counterfeit medicines entering the EU market does not adequately address the API quality issues, and it does little to improve upon the present Directive (2001/83/EC) with regard to patient safety.
For more information, visit www.efcg.cefic.org.