Regulatory Newsletters

CTIS Highlights issue 5 published
Start of pilot program of the EMA-FDA parallel scientific advise for hybrid/ complex generic
"Human Medicines Highlights" EMA Newsletter - October 2021 issue
Launch of GMP inspection management in IRIS
Deadline extension to register for (new) sites for Medicinal Products during MAA and variations (IA,IB,II) in Organisation Management Service (OMS) : new mandatory deadline of 1 November 2021
EMA's SME office report 2016-2020
Guidance on applying in parallel with an EU marketing authorisation application
EMA public statement on additional measures to allow experts to focus on COVID-19 activities