The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
European Medicines Agency International (EMA) cooperation head, Emer Cooke, made the comment at the DIA’s 49th annual conference in Boston, US last week.
She explained that: "80% of our [those used in Europe] active pharmaceutical ingredients are not coming from the European Union" and that the idea behind the new import laws - which are part of the Falsified Medicines Directive - is that authorities in key supply hubs are able to regulate manufacturers more effectively than European authorities.
“We think regulators can manage their own markets better than we can from afar. So we really want to work with regulators outside the EU to see how they manage their supervision of active substance manufacturers because we want to be able to rely on them.”
This proposal – particularly the requirement that regional regulators confirm API quality in writing - initially met with resistance when put forward in 2011, according to Cooke, who said: “When this [the new import laws] first came out everyone said it was a ridiculous way of doing business. ‘What?! You want us to regulate something that goes outside our market that is not for us?!”
But that situation changed has in the last few years and months and now, just one day before the import regulations come into effect, the system is up and running and operating as intended, she continued.
“Things have moved on. From denial and ‘it’s never going to happen,’ ‘we are going to have shortages’ and the ‘European patient is never going to have an API again’ to a position where we can say yes, we’ve worked with China, India, the US and Japan and we have a system in place that means that we can rely on the products that are coming from these countries.”
Cooke cited the EMA’s cooperation with authorities in India – which issued a list of approved manufacturers last month - as an example of how the new system is working to weed out those that do not meet the required quality standards.
“When we looked at the numbers [of Indian manufacturers issued with quality confirmations] there were not as many manufacturers as we thought there would be. And they said ‘we didn’t think some of them should be exporting to you’ and that’s exactly what we wanted to happen.”
Whether drugmakers concerned about potential API shortages will view the fact that Indian authorities have issued a lower than expected number of manufacturers with 'written confirmations' in the same positive light remains to be seen.