Immune-system diseases

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This page brings together the Agency's latest information on diseases affecting the immune system.

It lists:

the ten newest and recently updated medicines authorised for the treatment of immune-system diseases in the European Union (EU);

the most recent opinions on medicines for immune-system diseases that are pending authorisation by the European Commission (EC);

the latest news and press releases related to immune-system diseases;

the Agency's events on topics related to immune-system diseases.

 

This page includes information related to HIV and AIDS. To see information on HIV- and AIDS-related topics only, see HIV and AIDS.

News

Events

  • 24/11/2017 - 25/11/2017

    EMA

    Third tripartite meeting held between EMA, PMDA and FDA to discuss regulatory approaches for the evaluation of antibacterial agents

    This meeting built on the work of previous two meetings between the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in the way these regulators approach the evaluation of antimicrobials, aiming at identifying further areas for convergence. The three agencies agreed to further align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections. They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents and discussed he importance of characterising the pharmacokinetic-pharmacodynamic relationship and monitoring the benefit-risk balance throughout the medicine lifecycle. The agencies plan to meet again in 2018. ... Read more