However, a surprise directive by the National Association of Pharmacy Regulatory Authorities early in 2010 forced the NHPD to enact amendments to the regulations in order to address the backlog.
Furthermore, if, after a product has been launched with an EN, the NHPD (upon eventual review of the license application) concludes that the product is not backed by sufficient scientific evidence to support efficacy, the NHP supplier may be forced to remove the product from the market.
As of January 1, 2006, all facilities were required to have this license and NHPD enforcement action was initiated in this area.
Applicants must submit evidence to support a claim they wish to make associated with the product, with NHPD allowing therapeutic claims, risk reduction claims and structure-function claims, in addition to non-specific claims.
Any products with an identified health risk are an immediate priority for NHPD enforcement activity.
The process of acquiring an NPN involves submitting a product license application to NHPD along with safety and efficacy information to support the claim.
NHPD has posted numerous monographs, so if a company wishes to make a simple monograph claim, they need only refer to the monograph and a shorter turnaround time theoretically applies.
It quickly became apparent under the new regulations that the NHPD would be unable to deliver the quick turnaround times it originally predicted and that a backlog of product submissions would evolve.
One challenge to this system is that the ingredient files are not reviewed for completion by NHPD until they are actually referenced in an NPN submission.
In an April presentation to industry, NHPD admitted that because of the current backlog in product approvals, a system redesign would be required for a long-term solution.
Generally, the Product License Application (PLA) must contain information to allow the NHPD to evaluate the safety, efficacy and quality of the NHP, as well as the proposed label text(s); however the extent of the required information depends on the submission type.
The NHPD defines a claim as "a statement that indicates the intended beneficial effect of a NHP when used in accordance with the labeled dose (i.