Regulatory News - July 2018

EMA launches a new secure online portal for sponsors to submit applications for orphan designation and to manage post-designation activities

EMA published its workshop report on how to better apply the Paediatric Regulation to boost the development of medicines for children. A fact sheet and a video are also available.

EMA restricted use of Keytruda (pembrolizumab) and Tecentriq (atezolizumab) as first line-treatments for urothelial cancer

EMA begins a review of medicines containing the painkiller metamizole

EMA pre-authorisation procedural advice for users of the centralised procedure

EMA post-authorisation procedural advice for users of the centralised procedure

FDA published first CSR in the pilot program: Erleada

Draft guidance “Patient-focused drug development: collecting comprehensive and representative input”

Press Release: Statement from FDA Commissioner Scott Gottlieb, MD, on new policies to reduce the ability of brand drug makers to use REMS programs as a way to block timely generic drug entry, helping promote competition and access

ICH S9 guideline on nonclinical evaluation for anticancer pharmaceuticals- Qs&As