Additional contraceptive options are needed to expand the availability, accessibility, and acceptability of long-acting contraception globally. Microneedle array patches (MAPs) are a novel drug delivery system with the potential to help address this need. Regulatory guidance applicable to this novel delivery system is limited, and no drug-containing MAPs have been granted marketing authorization to date in any health area.

To support the timely and streamlined development of long-acting LNG MAPs in the absence of regulatory precedent, PATH sought product-agnostic regulatory scientific advice from agencies recognized as operating at an advanced level of performance.

The white paper, Advancing Long-Acting Levonorgestrel Microneedle Array Patches: Early Regulatory Insights to Guide Development, summarizes the scientific advice received from the agencies and contextualizes its implications for advancing LNG MAP development.