Beginning July 2, all APIs (active pharmaceutical ingredients) sent to the European Union will require written confirmation from local regulators that their manufacturing practices comply with European GMP (good manufacturing practices) due to the Falsified Medicines Directive enacted in 2011.
The EC’s (European Commission) decision to grant the waiver may have saved the EU from drug shortages as many of the drugs produced in the region rely on US APIs.
“Working with the EC, the FDA has helped U.S. pharmaceutical companies avoid duplicative administrative efforts which impede trade and delay the manufacture of needed medicines,” FDA Commissioner Margaret Hamburg said. “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.”
As far as other countries are concerned, the results of expected compliance still vary. The EC previously granted waivers to Australia, Japan and Switzerland, though the vast majority of APIs are imported from China and India.
A Beijing industry group announced earlier this month that some Chinese firms will not have the necessary written confirmations, while India’s CDSCO (Central Drugs Standards Control Organization) published a list of the companies that have obtained the confirmations, which the EC welcomed.
But there still seem to be some lingering concerns about shortages as the UK’s MHRA last week announced a contingency plan that would allow API imports without the written confirmation if there are drug supply concerns. The pharmaceutical industry is lobbying for other EU Member States to take similar action.