The FDA Export Reform and Enhancement Act of 1996 – a brief understanding

The FDA Export Reform and Enhancement Act of 1996 is a landmark Act passed by the American Congress. A landmark legislation in that it instilled and reinforced the concept of free global trade; the FDA Export Reform and Enhancement Act of 1996 removed the need for American pharma companies to obtain FDA approvals for the products that they export to select markets. Following the passage of the FDA Export Reform and Enhancement Act, American companies need to only get approval of the respective countries regulatory authorities.
One of the highlights of the FDA Export Reform and Enhancement Act of 1996 is that it was one of the very few Acts that were put into effect almost immediately after being passed into law. This perhaps reflected the immediacy of the benefit the Act wanted to bestow on American companies.
The overriding highlight of this legislation is that it almost totally obviated the need for FDA approval for products that were being exported to a few select countries. American pharmaceutical companies saw this as a great concession that they got to export their products, as it completely helped them bypass the tedious FDA approval process.
The FDA Export Reform and Enhancement Act of 1996 allowed the following categories of non-FDA regulated products to be exported to any country of the world:

• Any unapproved new drug
• Human biological product
• Animal biological product, or
• Medical device

The Listed Countries

Subject to marketing approval by the respective regulatory bodies of the 25 developed nations; American companies can market their products to what the FDA Export Reform and Enhancement Act of 1996 considers “Listed Countries”:

• Australia
• Canada
• Israel
• Japan
• New Zealand
• South Africa
• Switzerland, and
• The European Economic Area

Requirements of the FDA Export Reform and Enhancement Act of 1996The FDA Export Reform and Enhancement Act of 1996 prescribes vastly liberalized general requirements which pharma companies need to adhere to in order to be able to export non-FDA approved medical products to the Listed Countries. The following core components have been greatly relaxed or exempted for export approval:

• 510 (K) requirements for Class I and Class II devices
• GMP requirements
• Simple Notification
• Devices that carry imminent hazards
• Labeling requirements

Requirement from receiving countriesFinally, the FDA Export Reform and Enhancement Act of 1996, upon the insistence of the Listed Countries, ruled that manufacturers who wanted to benefit from this legislation had to obtain clearance from the FDA that there were no regulatory or legal actions pending on these companies.

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