Human medicines: highlights of 2023

16 January 2024 - In 2023, EMA recommended 77 medicines for marketing authorisation.  ...

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PRIME enables earlier availability of life-changing medicines

3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...

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Human medicines: highlights of 2021

15 February 2022 - In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance ...

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EMA starts safety review of Janus kinase inhibitors for inflammatory disorders

11 February 2022 - EMA’s safety committee, PRAC, has started a review of the safety of Janus kinase (JAK) inhibitors ...

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EU regulator starts safety review of coronavirus drug

3 October 2020 - The European Medicines Agency says it has started a safety review after some patients taking the ...

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EMA starts rolling review of remdesivir for COVID-19

30 April 2020 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of ...

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Human medicines: highlights of 2019

9 January 2020 - EMA has published a review of its key recommendations in 2019 on the authorisation and safety ...

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Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

12 April 2019 - EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of ...

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Procedural update on submission of Type I variations to EMA in March, April and May 2019

26 February 2019 - EMA is encouraging marketing authorisation holders intending to submit Brexit-related Type IA and Type IB variations ...

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EMA to launch new corporate website on 27 September 2018

24 September 2018 - Fresh design and improved features to provide better user experience ...

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Human medicines: highlights of 2017

23 January 2018 - 92 medicines recommended for approval, including 35 with a new active substance. ...

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EMA’s procedural handling of safety review was complete and independent

17 October 2017 - European Ombudsman concludes her inquiry into the HPV vaccines referral. ...

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EMA publishes comments on Member States’ hosting bids

3 October 2017 - Accessibility for delegates and experts and staff retention are key to ensure Agency’s ability to function ...

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Conditional approval of medicines by the EMA

2 May 2017 - The process fails to improve the evidence after early licensing. ...

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Simpler website navigation for regulatory information on human medicines

1 December 2016 - New navigation to help users find information more easily ...

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