The European Fine Chemicals Group (EFCG) argues in a document published today that neither the existing EU directive 2001/83/EC on finished drugs nor the newer Falsified Medicines Act (2011/62/EU) will prevent low quality and dangerous active pharmaceutical ingredients (API) from being imported to Europe.
Chief among the group’s concerns is that the directives do not require that API facilities outside Europe be inspected by regulatory bodies. Instead the EU makes importers responsible for ensuring that manufacturing complies with good manufacturing practices (GMP) by suggesting that they conduct site audits.
“There is a big difference in the quality of an audit and an inspection performed by a national authority,” the EFCG argued, adding that “The date of an audit and its limited scope has to be pre-agreed with the supplier but and inspection date is imposed on a supplier and they can demand to see everything.”
The group also raises doubts about the plan to require that APIs imported from outside the European Union are accompanied by written confirmation they were produced according to GMP or equivalent standards, suggesting that approach is not robust enough.
“Most current suppliers in such third countries will take a very long time to achieve EU standards of API manufacturing and until they so 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).”
Level playing field
Instead the EFCG - which represents many major Europen fine chemicals firms - reiterated its call for mandatory inspections of all global API sites by regulators to ensure quality and “level the playing field and significantly reduce the competitiveness gap between all API manufacturers”.The organisation pointed to joint inspection programmes as an efficient approach to implementing such inspections.
The comment about competitiveness is based on the organisation's contention that because facilities in key API export hubs like China and India are only rarely inspected, manufacturers in such countries have been able to cut prices because they save on compliance costs.
The European Commission was not able to respond to in-Pharmatechnologist.com’s request for a response ahead of publication.