FDA and EMA launch complex generics advice program

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for the FDA’s complex generics and of marketing authorization applications (MAAs) for the EMA’s hybrid products.

This program is an expansion of the FDA and EMA’s existing PSA for new drugs and biological products. It has been launched to allow FDA and EMA assessors to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic drug or hybrid products.

It is hoped that applicants will gain a deeper understanding of the basis of regulatory decisions from both agencies and optimize their global product development program, and also avoid unnecessary replication of studies or unnecessary testing methodologies to satisfy both agencies, which can prolong the development of complex generics.