From Our Perspective
CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients
By: Sarah Ibrahim, PhD., Associate Director of Stakeholder and Global Engagement, Office of Generic Drugs, CDER
CDER’s Office of Generic Drugs (OGD) and the European Medicines Agency (EMA) launched a voluntary pilot program to facilitate concurrent discussions between generic drug applicants and the two regulatory bodies, with the ultimate goal of improving patient access to harder to develop generic drugs. This pilot program is an expansion of FDA and EMA’s existing Parallel Scientific Advice (PSA) program and focuses on complex generics/“hybrid medicines” (an EMA term for medications that loosely corresponds to complex generics).
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