With the deadline for compliance with the Falsified Medicines Directive looming, the European Commission (EC) cleared US based API manufacturers to export APIs to European Union (EU) countries in a much anticipated decision. While many pharmaceutical companies and their contract manufacturers had worked to put contingency plans in place, the decision is certainly a welcome development and should help prevent costly supply chain interruptions.
As a bit of background, the EC put the Falsified Medicines Directive (the Directive) into place on July 1st 2011 to help prevent counterfeit drug importation into the Europe Union. The Directive requires all Active Pharmaceutical Ingredients (API) to be confirmed as EU GMP compliant by the exporting country. This could be accomplished in one of three ways:
1) The “third country” can apply to be listed as exempt by the European Commission, confirming that they have regulatory standards equivalent to those in the EU.
2) Companies that export APIs must obtain written confirmation from their respective regulatory bodies confirming that the API is EU-GMP compliant.
3) In extreme cases, waivers can be granted for manufacturers with EU-GMP certificates if options one and two cannot be met and it will create a drug shortage.
The first option offers the most straight-forward and easiest pathway to market and is the pathway the United States chose to take. With the listing, the US joins Switzerland, Japan and Australia on the white-list and can freely export APIs to EU countries. Without the last minute listing, US based companies would have been forced into the second option. The second option would have required companies to apply for an export permit from the FDA, accompanied by documentation showing the product was manufactured in an EU-GMP compliant manner. This process of obtaining an export permit may have added weeks to the API lead time, impacting drug supply.
It will be interesting to see how the new provisions impact other prominent API manufacturing companies including Brazil, China and India, as they have not obtained “third country” listing, and will look to certify each API shipment as EU GMP compliant. There is also the issue of manufacturer’s in other countries without EU-GMP certificates that may not be able to receive written confirmation from their regulatory bodies. In these cases, EU based pharmaceutical companies may be forced to look at alternative suppliers.
Importantly, these provisions do not apply to investigational products. For more on this issue, I recommend this webinar, presented by Rx-360.