Two industry groups with skin in the game say they want foreign API plants inspected by the FDA. And they're willing to pay for it.
The Society for Chemical Manufacturers and Affiliates' Bulk Pharmaceutical Task Force and the European Fine Chemicals Group of the European Chemical Industry Council are calling on the FDA to mandate the inspections. Both say they're willing to pay fees for checks of member-owned facilities outside the U.S.
In a proposal to the FDA, the pair notes inspections in high-risk regions like China and India are almost non-existent when compared with the U.S. and Europe. This lack of inspections poses a risk to public health.
The groups ask the regulator to consider an annual facility registration fee of $1,000 to $10,000 for the setup and maintenance of a facilities/APIs database. In addition, sites will pay a fee for each inspection, with payment made prior to the agency's visit.
A successful inspection would earn the site a GMP certificate for the specific APIs made there. Also to be noted is the period for which the certification is valid.
The proposal "could be implemented relatively quickly," its drafters say. And it "will bring FDA into line with best practice."
- see the announcement
- here's the proposal