FDA and EMA launch pilot programme to provide scientific advice on complex generic/hybrid products

The US Food and Drug Administration (FDA), in partnership with the European Medicines Agency (EMA), has launched a pilot programme to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for FDA’s complex generic drug products and of marketing authorisation applications (MAAs) for EMA’s hybrid products, a statement from FDA said.

This pilot programme is an expansion of FDA and EMA’s existing PSA for new drugs and biological products. The goal of this programme is to allow FDA and EMA assessors to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic drug/hybrid products, it further added.

The collaboration between FDA and EMA via the PSA pilot programme is expected to provide applicants with a deeper understanding of the basis of regulatory decisions from both agencies, optimise applicants’ global product development programme, and help applicants avoid unnecessary replication of studies or unnecessary testing methodologies to satisfy both agencies, which can prolong the development of complex generic products, the statement emphasised.

Further, according to it, applicants can now submit a request for a meeting with both agencies to discuss specific questions regarding the development of a complex generic drug/hybrid product. Meeting requests will be received until FDA and EMA determine the number of completed PSA meetings is sufficient to assess the pilot programme. During and after the conclusion of the pilot, each agency will evaluate the benefits and challenges of the programme, including the resources required, and determine the next steps.