For the first time, EMA has issued a list of regulatory science topics that need further research to close gaps and improve medicine development and evaluation to enable access to innovative medicines for patients.
This is part of the EMA Regulatory Science Research Needs (RSRN) initiative, targeted to researchers and funding organizations held online on January the 18th.
Although some in silico related approaches, such as AI and machine learning or alternatives to animal models, are accounted for in that RSRN list, the term in silico does not appear as such and other computational modeling and simulations methods are under-represented. This shows that further efforts are necessary for raising regulators awareness about the need for a regulatory framework and standards for in silico technologies. EMA is now calling for feedback and recommendations from researchers about research topics not yet listed.
Visit the EMA website for more details.