News
FDA & EMA launch parallel scientific advice program for complex generic drugs
In a move that marks an important step in the alignment of scientific evaluations of complex generic/hybrid products, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) recently announced the launch of a new joint pilot program.
The program, first announced in September, aims to provide parallel scientific advice to (1) applicants of abbreviated new drug applications for FDA’s complex generic drug products and (2) marketing authorization applications for EMA’s hybrid products.
Through the collaboration, applicants will gain a deeper understanding of both agencies’ recommendations and regulatory decision-making processes. The program will also optimize the application process, helping to avoid unnecessary study replications, and ultimately reducing the approval time.
Commenting on the news, Jon de Vlieger, NBCD Working Group Coordinator said: “This is a very important step and a great achievement by all organizations involved. The successful collaboration between the FDA and EMA is very much needed to streamline regulatory decisions regarding the development of life saving medicines. I look forward to seeing the first results from the pilot and to continuing the world-wide discussions on science-based regulations for these complex drug products.”
For more information on the current regulatory framework for NBCDs, take a look at our publication list.
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The Non-Biological Complex Drugs Working Group (WG) was established in 2009, to stimulate discussion of the safety and efficacy of NBCD innovation and follow-on products. The WG, coordinated by Lygature, aims to ensure patient benefit through a science-based approach for the approval of NBCD products and follow-on versions.