The EMA and the FDA have launched a pilot program in which the agencies will give parallel scientific advice (PSA) to applicants submitting MAAs for hybrid products and ANDAs for complex generic products, including inhalers and nasal sprays. The program began on September 15, 2021 and will continue to accept meeting requests “until a sufficient number of PSA meetings are held to support the pilot program.”
Meetings held as part of the pilot program between the EMA, FDA, and the applicant will focus on a specific development issue and are expected to take approximately one and a half hours. One reason for submitting a meeting request under the pilot program might be to find out if both agencies might accept the same study design, the agencies suggest, noting that “Studies that may benefit from the PSA process include comparative non-clinical and comparative clinical studies involving innovative bioequivalence study designs and the use of methodologies such as modelling and simulation.”
According to the announcement, “Such interactions are expected to increase dialogue between the two agencies and applicants from the beginning of the lifecycle of a hybrid/complex generic drug product. Successful collaboration may provide applicants with a deeper understanding of the basis of regulatory decisions, optimize product development, and avoid unnecessary replication of studies or unnecessary testing methodologies.”
Read the FDA and EMA document.
