What will happen after the new NHP Regulations come into effect in January 2004?
It will take six years to fully implement the new Regulations. During the first two years, we’ll focus on product safety by making sure that all manufacturers have site licences and are using the approved GMPs. Approximately 10,000 NHPs (of the estimated 50,000 to 60,000 on the market) currently have Drug Identification Numbers (DINs) issued under the FDR. These products will have six years to transition to the new framework. The NHPD will be targeting compliance and enforcement actions on a risk-based approach to gradually bring the remaining products into full compliance throughout the first four years that the Regulations are implemented. There is some uncertainty and a lot of work associated with implementing such a novel regulatory approach, but we’re committed to being vigilant in our follow-up activities so that consumers can realize the maximum benefits. In closing, how would you respond to potential critics who might say that support for CAHC and the new regulatory approach fo
