EFCG says EU API import laws are ineffective
Calls for mandatory inspection by regulatory authorities
The European Fine Chemicals Group (EFCG) is proposing a global harmonisation 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 through 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.
EFCG, which represents more than 40 EU fine chemical manufacturers and trade bodies involved in the global pharmaceutical supply chain, argues that the new Falsified Medicines Directive (2011/62/EU), designed to minimise counterfeit medicines entering the EU market, does not adequately address API quality issues and does little to improve upon the present Directive (2001/83/EC) with regard to patient safety.
The group is concerned that the directives do not require that API facilities outside the EU are inspected by regulatory bodies and instead put the responsibility for ensuring that manufacturing is conducted in compliance with good manufacturing practices (GMP) on importers through audits.
‘There is a big difference in the quality of an audit and an inspection performed by a national authority,’ the EFCG says.
‘The date of an audit and its limited scope has to be pre-agreed with the supplier but an inspection date is imposed on a supplier and they can demand to see everything.’
The EFCG also raise doubts about the quality of future API imports to the EU from developing third countries on which the EU is already heavily reliant.
‘Most current suppliers in such third countries will take a very long time to achieve EU standards of API manufacturing and, until they do, the risk control mechanisms to protect the EU public – a written confirmation and/or an audit by a Marketing Authorisation Holder – are less reliable than that provided by an inspection by an EU (or equivalent) authority.’