From July 2 all active pharmaceutical ingredients (API) shipped to the European Union (EU) will need to be accompanied by “written confirmation” from local regulators that they were produced in accordance with European good manufacturing practices (GMP), or equivalent, standards.
Australia, Japan and Switzerland each sought and were granted exemption from the import requirements in 2012 after an EU review found that quality standards covering API production in the three countries are equivalent to those in Europe.
For APIs made in the US the position is somewhat different. The US Food and Drug Administration (FDA) asked for the requirements to be waived in January but – to date – has not been granted exemption by the EU, which says the GMP equivalence assessment is ongoing.
This means that US made actives lacking ‘written confirmation’ will not be allowed into the EU from July. This contrasts with APIs made in facilities outside the US that have been audited by the US FDA that – according to an European Commission (EC) Q&A – can use the regulators assessment to confirm compliance with quality requirements.
Supply threat
Any interruption in US APIs shipped to the EU could have serious consequences according to John DiLoreto, Executive Director of the Society of Chemical Manufacturers & Affiliates Bulk Pharmaceuticals Task Force.
He told in-Pharmatechnologist.com that: “The continued availability of active pharmaceutical ingredients from the US to the EU is of utmost importance. After July 2, the decrease of APIs could threaten drug supplies unless the US is granted a country exemption from the EU FMD[Falsified Medicines Directive] written confirmation requirement.
Despite this warning, DiLoreto is hopeful a resolution will be found ahead of the July 2 deadline.
“Given the FDA’s commitment to enforcement of GMPs and the strengthening of requirements on generic drug producers in the US through the Generic Drug User Fee Act, BPTF members are hopeful the exemption will be granted in time to ensure a continued supply of safe drugs into the EU.”
This optimism was echoed by the European Commission (EC) which told this publication it "is putting in place every effort and we are confident that the US will be listed before July 2."
SOCMA’s comments follow just a day after the MHRA said it would allow the importation of APIs without ‘written confirmation’ if the facility where they were made has a GMP certificate from an appropriate authority and has been audited by the importing drugmaker.