The European Fine Chemicals Group (EFCG) is proposing a global harmonization of the rules and regulations governing the manufacture of active pharmaceutical ingredients (APIs) to level the worldwide playing field to ensure the quality of APIs and medicines containing them meet the high standard recognised by the developed economies (ICH Q7).
This should be achieved via mandatory inspections of all global API manufacturers via a Mutual Recognition Agreement (MRA) approach and managed by the National Regulatory authorities to share scarce inspection resources and to avoid the present duplication.
This message is at the core of the latest EFCG position paper aimed at all stakeholders in the global API supply chain, including the Regulators, previewed during their October press conference at the CPhI exhibition in Madrid and repeated in their recent joint response (with APIC and SOCMA) to the EU-US Public Consultation on the future of EU-US trade and economic relations, which provides proposals for the EU-US High Level Working Group on
Jobs and Growth and to the EU-US High Level Regulatory Cooperation Forum.
EFCG believes that 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 that in reality it does little to improve upon the present Directive (2001/83/EC) with regard to patient safety.
Evidence of illegal API manufacturing activity in Asia since 2003 is given in the paper, including the 2008 Chinese-sourced heparin case in the USA that caused >100 deaths due to a deliberately included and undeclared impurity.