Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity

2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...

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Regulation on EMA’s extended mandate becomes applicable

1 March 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management of medicinal products and medical devices becomes ...

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European medicines regulatory network adopts EU common standard for electronic product information

22 February 2022 - The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines ...

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BioNTech plans to make vaccines in shipping containers

19 February 2022 - These standardised factories could be quickly scaled up to expand capacity worldwide. ...

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Regulatory decisions diverge over aducanumab for Alzheimer’s disease

19 February 2022 - The EMA refused marketing authorisation for aducanumab (Aduhelm), a monoclonal antibody targeted at amyloid β, in December ...

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European Commission approves Oxbryta (voxelotor) for the treatment of haemolytic anaemia in patients with sickle cell disease age 12 years and older

16 February 2022 - The first sickle haemoglobin polymerisation inhibitor approved in Europe, Oxbryta increases haemoglobin levels and reduces sickling ...

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Merck struggles to win European approval for Covid antiviral pill

16 February 2022 - EMA said to be unlikely to grant marketing authorisation to molnupiravir this month after ‘problematic’ data. ...

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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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EU ramps up collection of public health data to improve drug reviews

9 February 2022 - By 2025, centre is set to conduct over 100 studies per year. ...

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Initiation of DARWIN EU Coordination Centre advances integration of real world evidence into assessment of medicines in the EU

9 February 2022 - EMA is initiating today the establishment of the Coordination Centre for the Data Analysis and Real ...

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A stronger role for EMA

31 January 2022 - The regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices has ...

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Regulatory harmonisation of clinical trials in the EU: clinical trials regulation to enter into application and new clinical trials information system to be launched

25 January 2022 - On 31 January 2022, the clinical trials regulation will come into application harmonising the submission, assessment and ...

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COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy

18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...

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Accelerating clinical trials in the EU: for better clinical trials that address patients’ need

13 January 2022 - Today, the European Commission, the Heads of Medicines Agencies and the EMA have launched an initiative to ...

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Global regulators discuss path towards regulatory alignment on response to Omicron variant

13 January 2022 - On 12 January, regulators from around the world discussed the global regulatory response to the COVID-19 Omicron ...

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