“Yeah, right,” you say. But officials at USDA’s Animal and Plant Health Inspection Service have announced plans to streamline the approval process for veterinary biologics, such as vaccines and bacterins, and for deregulating genetically engineered organisms.
According to APHIS figures, the new system will cut about 100 days, or 20 percent, from the current 500 days needed to process a license application for a veterinary biologic product.
A common complaint among those in the animal-health business is the lengthy, and costly, process to gain approval and bring a new product to market. Ed Avalos, USDA undersecretary for marketing and regulatory programs, says companies have estimated that a one-year delay costs them $5 million to $10 million.
“What’s important is that the changes we are undertaking will not only have a direct benefit for the biologics businesses but also the livestock industry,” Avalos says. “Our new process will create valuable savings and help drive growth.”
Of course, it’s in the best interest of producers, consumers and animal-health companies that vaccines and other products are safe and effective, which is the point of the licensing process. APHIS officials say the agency can maintain its standards and achieve time savings through several efficiency improvements, including:
- Allowing industry to provide a project development plan to identify the steps that must be completed in order to gain licensure.
- Documenting mutually agreed upon standards.
- Simplifying the product reference qualification/requalification process for older legacy products and extending the use of these references to 15 years.
- Standardizing the statistical data submissions by industry in support of licensing and other services.
- Simplifying the conduct and review of studies that support the efficacy of veterinary biologics while still maintaining high-quality data review.
- Streamlining the process that occurs once all of the materials necessary to recommend product licensure are submitted.
APHIS also announced plans to streamline the decision process on petitions for nonregulated status for genetically engineered plants. APHIS grants such petitions when it determines that a GE product does not pose a plant pest risk and should not be subject to APHIS regulation. “With these improvements, APHIS will significantly reduce the average length of the petition process while maintaining strong oversight,” Avalos says.