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EFCG Calls for Regulatory Inspections of API Manufacturers

The European Fine Chemicals Group (EFCG) has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the EU market. EFCG believes that such inspections will help to harmonize the global rules and regulations concerning APIs and pharmaceutical products. The EFCG expressed doubts about the effectiveness of the EU’s plans to require that APIs imported from outside Europe be accompanied by certification from the exporting country’s authorities that they were made according to EU GMP or equivalent, stating “Most suppliers in such third countries will take a very long time to achieve EU standards of API manufacturing and until they do so the risk control mechanisms to protect the EU public – a written conformation and or an audit by a marketing authorisation holder – are less reliable than that provided by an inspection by an EU (or equivalent) authority”.

The group proposes that inspections be conducted using a Mutual Recognition Agreement (MRA) approach involving national regulatory authorities sharing inspection resources. An EFCG position paper estimates that the cost of inspections will be approximately EUR 2.6 million ($3.3 million) over a three-year period and suggests that financial resources could come from participating companies wishing to sell their APIs in the EU marketplace.

During the past decade, the market for generic APIs has increased and a greater number of APIs used in European medicines are sourced from China and India. API manufacturers in these countries, however, are rarely inspected by EU authorities. In a position paper, EFCG claims that 70% of all APIs consumed in Europe are imported from China and India. With the vast majority of manufacturers unregulated, some APIs may contain impurities or may be in breach of EU quality standards. Cases cited by the position paper include glycerine contaminated with antifreeze (2006), Heparin contaminated with chondroitin sulphate (2008) and contaminated cardiovascular drugs in Pakistan (2012).

Assuming 860 API manufacturing sites were inspected once every three years by 33 inspection authorities (EU (27), USA, Australia, Japan, Switzerland, New Zealand, Canada) to the same standard (ICH Q7) and that they are willing and able to share the inspection outcomes, then around eight sites need to be inspected each year by each inspection authority, states the position paper.

EFCG has been calling for mandatory inspections of all global API sites since 2004.