Starting today all active pharmaceutical ingredients (APIs) shipped to the European Union (EU) will need to be accompanied by a ‘written confirmation’ of quality from a regulator in the source country.
The only exceptions are APIs made in Australia, Japan, Switzerland and the US, which have been granted exemption from the regulations.
The new import requirements – which are part of the European Falsified Medicines Directive – have been a subject of concern among drugmakers, industry groups and regulators worried that Governments in key supply hubs would not have oversight systems in place in time.
No immediate shortages
These concerns appear to have receded somewhat, at least for EFPIA, which told in-Pharmatechnologist.com that: “In the immediate future, no drug shortage is foreseen.
“The next 6 months will nevertheless be critical while the system matures, and as written confirmations remain to be issued from major importing countries including China.
The industry group added that: “All parties must remain actively engaged till the system becomes fully operational and provides more predictability.”
While China may still be a source of concern, in India – which is also a major source of the drug actives used in the EU – the situation has improved.
Last month, we reported that Indian drug industry regulator CDSCO – the Central Drugs Standard Control Organiszation – had published a 40-strong list of manufacturers it had issued with the written confirmations needed under the new import rules.
The move was welcomed by the European Commission (EC) which told this publication that it “facilities compliance checks by EU Member State authorities.”
Since then the list has been updated to include around 160 manufacturing facilities operated by key suppliers such as Teva, Ranbaxy, Cadila, Aurobindo, Niocon, Lupin, Jubilant Life Sciences, Wockhardt, Piramal and Shasun Pharma.