The European Commission has granted the US an export waiver, which means that, from July 1, US companies will no longer need to obtain an export certificate from the Food and Drug Administration (FDA) before shipping certain pharmaceutical products to the European Union (EU).
Currently, all US companies shipping active pharmaceutical ingredients (APIs) to the EU are required to submit documentation to the FDA beforehand, to show that the product was manufactured according to European Good Manufacturing Practice (GMP) standards. On approval, the FDA provides an export certificate.
The move follows a formal “listing request” submitted by the FDA at the beginning of the year. This asked the Commission to consider the FDA’s GMP standards to be at least equivalent to those in Europe, which are those of the International Conference for Harmonisation (ICH) Q7.
The FDA subsequently underwent a comprehensive audit and inspectional oversight of APIs by the EU during May 13-20.
Commenting on the waiver grant, FDA Commissioner Margaret Hamburg said that, working with the European Commission, the FDA has helped US pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines.
“At the same time, 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,” she added.
The import of APIs falls under the EU Falsified Medicines Directive, which was issued on June 8, 2011 and comes into force on July 2.
In addition to the US, the EU has previously granted such export waivers to Switzerland, Japan and Australia, while other countries which have requested to be included on the so-called “third country” list are Israel, Singapore and Brazil.
And last month, India introduced new GMP guidelines for its domestic drugmakers to comply with the EU Directive. From July 2, India will be required to certify that locally-made APIs being imported into the EU are compliant with the legislation; at present, such certification is carried out by the importing nation.
