The U.S. FDA in partnership with the European Medicines Agency (EMA), launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for FDA’s complex generic drug products and of marketing authorization applications (MAAs) for EMA’s hybrid products.
This pilot program is an expansion of FDA and EMA’s existing PSA for new drugs and biological products. The goal of the PSA pilot program being launched today is to allow FDA and EMA assessors to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic drug/hybrid products.
Successful collaboration between FDA and EMA via the PSA pilot program is expected to provide applicants with a deeper understanding of the basis of regulatory decisions from both agencies, optimize applicants’ global product development program, and help applicants avoid unnecessary replication of studies or unnecessary testing methodologies to satisfy both agencies, which can prolong the development of complex generic products.
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