International – EMA-FDA parallel scientific advice program has ‘limited’ uptake

A review of the last five years of the Parallel Scientific Advice (PSA) program between the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) shows that the agencies received a total of 37 applications from sponsors of new medicines and accepted 70% of requests.

The PSA program, which launched in 2005, provides a mechanism for sponsors of new medicines to seek concurrent advice from regulators in the US and Europe on scientific issues involved in product development. It is a voluntary program and is triggered by a request from a sponsor.

The review, which was conducted by FDA and EMA staff, was published in Therapeutic Innovation & Regulatory Science in March 2023. From 2017-2021, the agencies received 37 requests, of which 26 (70%) were accepted. Over the five-year period, four sponsors withdrew their requests or chose not to proceed, leaving 22 completed PSA procedures.

“Data from our 5-year review show that uptake of the PSA pathway has been limited – just four to seven procedures annually over the last five years,” wrote Shannon Thor, of FDA’s Europe Office, along with colleagues from both agencies…