US gains exemption from EU requirements on API imports
pharmafile | June 25, 2013 | News story | Manufacturing and Production |Â Â API, FDA, hamburgÂ
The US has joined the short list of countries from which suppliers can ship active pharmaceutical ingredients into the EU without written confirmation from a regulatory authority.
After 2 July, API suppliers from countries not on the list will have to obtain a certificate from their national regulatory agency indicating that the facility making the ingredients meets EU standards.
The US has joined a select group of countries – namely Australia, Japan and Switzerland – that have been deemed equivalent to the EU in terms of their regulatory oversight of APIs. Israel, Singapore and Brazil also sought exemption but have not yet been successful, according to the EC’s website.
The FDA requested formal recognition in January that its Good Manufacturing Practices (GMPs) be considered at least equivalent to those in Europe, after warning that failure to do so would place European consumers at risk of medicine shortages.
The US is one of the top four API suppliers into Europe along with Japan, India and China, so its inclusion goes a long way towards alleviating that risk. However, as it stands there are still concerns that with so many APIs sourced from India and China the requirement could lead to interruptions in supply.
To that end, the UK Medicines and Healthcare products Regulatory Agency (MHRA) implemented scaled down certification requirements – on a temporary basis – that would allow APIs to be imported provided the importing company has audited the site in the last three months, either directly or via an authorised third-party.
It has also been suggested that some marketing authorisation holders may decide to shift finished medicine production outside the EU if API sourcing becomes problematic, although as yet there is little evidence for such a shift.
The European Commission approved the FDA’s request following “a comprehensive audit last month of [our] regulatory and inspectional oversight of APIs”, said the US agency in a statement.
FDA Commissioner Margaret Hamburg welcomed the development, saying that the FDA and EC have helped US pharmaceutical companies “avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines”.
She also gave a vote of confidence in the EU’s requirements, which have caused some controversy and debate in recent months.
“The FDA applauds Europe for taking steps to protect its pharmaceutical supply chain and will continue to collaborate with its regulatory counterparts around the world to help keep our own supply chain safe,” said Hamburg.
The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organisation of the Society of Chemical Manufacturers and Affiliates (SOCMA) also hailed the announcement, noting that that will ensure a continued supply of safe drugs into the EU from the US.
John DiLoreto, executive director of the BPTF, sad the group supports negotiations between the US and the EU to eliminate trade barriers, to promote greater global harmonisation of current GMP requirements and to improve the safety of drugs throughout the supply chain.
Phil Taylor
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