FDA Globalization Act: Far-reaching Consequences for the Pharmaceutical Industry
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Represented by Congressman John Dingell, the Food and Drug Globalization Act of 2009 is introduced to the US House of Representatives (H.R. 759). This act contains points concerning the FDA's future orientation, some of which will have significant impact on the pharmaceutical industry. To name a few:
Registration of producers of medicinal products and applicable fees
Documentation of admissibility of imports of medicinal products into the USA. For this purpose, all companies exporting to the USA will have to be listed in a register and to pay an annual fee. In the context of the introduction of risk management plans, the manufacturers are meant to create a comprehensive electronic documentation of the supply chain of their products. Here, the supply chain should be traced and verified as far back as to the raw materials. In case the respective required documents cannot be provided, products may not be allowed to enter the USA.
Announcement of the actual country of origin of the active pharmaceutical ingredient and the finished medicinal product. This information shall be published on a website.
Higher number of inspections of manufacturers of active pharmaceutical ingredients and medicinal products. These are meant to be financed through fees. The frequency is meant to correlate with a risk assesed by the FDA (a frequency between 2 and 4 years has been suggested). This shall also apply to companies located n the USA. The fee is also meant to be charged in case of pre-approval inspections.
In the future, the manufacturers shall also conduct on-site audits of their suppliers within the framework of an integrated risk management.
Author: Wolfgang Schmitt On behalf of the European Compliance Academy (ECA)