1074 Revision Needs Formulator Feedback: AAPS PharmSci 360 2026

PharmTech sat down with with Ron Filler, PhD, president and CEO, Drug Development Consultants, at AAPS 2026, to discuss his presentation, “USP’s Pathway to Address Stakeholder Needs on Novel Excipients - Revisions to <1074> Excipient Biological Safety Evaluation Guidelines.” His presentation revolves around USP’s proposed revision of General Chapter 1074 Excipient Biological Safety Evaluation Guidelines.

The proposed framework examines how New Approach Methodologies (NAMs), weight-of-evidence assessments, and read-across structure analysis relation strategies can produce human-relevant safety data while reducing reliance on animal testing. This aligns with a wider regulatory shift as the European Medicines Agency is also encouraging NAMs in nonclinical safety assessment.

For formulators, Filler emphasizes early engagement with regulators. He says sponsors should seek agency guidance on what will be considered meaningful, so they can assemble the most efficient and cost-effective data package for marketing approval. He also cautions against expecting zero risk: “At the same time, there has to be the realization that there is an element of risk always present, that it never can be eliminated, but it can be reduced, and that is the process that we are in now, reduction in risk with an enhancement of efficacy for getting approval.”

Filler notes that USP first introduced the revision through a Stimuli Article to collect feedback before finalizing the chapter. He stresses that the process depends on industry participation. “So the dialogue between stakeholder and creator is an intimate one, and both are equal sharers in it.”

USP’s earlier survey work showed how much is at stake. Respondents reported that the current regulatory pathway makes novel excipients difficult to use, contributing to reformulations, discontinued programs, and delays.