The US FDA (Food & Drug Administration) and the EMA (European Medicines Agency) have launched a joint pilot designed to give parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines (as they’re referred to in the EU). The aim of the program is to expand on existing PSA for new drugs and biologics, as well as consider and exchange with applicants the agencies’ stances on scientific questions within the development phase of hybrid/complex generic products. As the definition of complex and hybrid drug differ between the two regulatory agencies, the pilot program will only include drugs that meet both the FDA’s and the EMA’s descriptions.
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