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EMA Fostering scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union

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Fostering scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union

EMA

2007 2009

2011 First ESVAC

report

First two orphan

medicines 2001

2005

2006 First conditional

approval First public 2017

hearing

2019 2020

1995 EMA established 1996

2000 2004 SME regulation

2014 2016 2018

2010 2012 2015

Relocation to the Netherlands completed

First two CAR-T medicines New Veterinary Medicines Regulation

Launch of PRIME (PRIority Medicines) scheme

Proactive publication of clinical data

First stem-cell medicine

First paediatric-use

marketing authorisation Falsified Medicines Directive

First marketing

authorisation for an ATMP Minor-use-minor-species

limited-market policy

First two biosimilar

medicines Paediatric Medicines

Regulation

Review of EU

pharmaceutical legislation

Orphan Medicines Regulation

First centrally authorised human medicine

Launch of international harmonisation programme for pharmaceuticals First centrally authorised

veterinary medicine

Clinical Trials Directive

First centrally authorised generic medicine New pharmacovigilance legislation First gene-therapy medicine

First joint strategy of EMA and national medicines authorities Amsterdam is announced as EMA's new home Mutual recognition

agreement on inspections

EMA elected as ICMRA chair First vaccine against Ebola

Herbal Medicines Directive SME office established

Riferimenti

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