BRIEF—CDER’s OGD and EMA’s program for complex generics

Advancing complex generic drug development is a critical part of the US Food and Drug Administration’s (FDA) goal to help patients access safe, effective and high-quality generic medicines, the agency stated.

Because of the extensive investments in research and development that may be needed, generic drug manufacturers and the regulatory agencies overseeing them are increasingly looking for proactive engagement opportunities during the early phases of drug development.

To that end, when Center for Drug Evaluation and Research’s (CDER) 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, the ultimate goal was improving patient access to harder to develop generic drugs.

This pilot program is an expansion of the 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).