EFCG Calls for Mandatory Inspections of All API Manufacturing Sites
The European Fine Chemicals Group (EFCG) is proposing a global harmonisation of the rules and regulations governing the manufacture of APIs to level the worldwide playing field and 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 paper1 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 response2 (with the Active Pharmaceutical Ingredients Committee (APIC) and US-based Society of Chemical Manufacturers and Affiliates (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 minimise 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 US that caused >100 deaths due to a deliberately included and undeclared impurity.
EFCG, www.efcg.cefic.org, APIC, www.efcg.cefic.org, SOCMA, www.socma.com.
References:
1 To harmonise the rules in order to guarantee the safety of pharmaceutical products and the citizen’s health: why are mandatory inspections needed?
2 Public consultation on the future of EU-US trade and economic relations. Proposals for the EU-US High Level Working Group (HLWG) for Jobs and Growth and the High Level Regulatory Cooperation Forum (HLRCF): October 2012.