5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...
18 July 2018 - Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals ...
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
12 June 2017 - EMA, PMDA and FDA align data requirements and agree on areas of convergence. ...