Regulatory News - January 2018

The CMDh released for public consultation a guideline „on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs“. Further information on this new follow-up procedure (“PSUFU”) to address specific authority requests received within PSUSA procedures for nationally authorised products is available here.

A draft qualification opinion on PROactive in chronic obstructive pulmonary disease (available here) has been released for public consultation.

The EMA’s second Awareness Session for international regulators, academia, and non-governmental organisations will take place in London on 8 9 March 2018. Further information is provided here (draft programme here).