OPEN framework extended to a wider range of medicines

20 July 2023 - EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a ...

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International regulators and WHO call for wider public access to clinical data

7 May 2021 - The International Coalition of Medicines Regulatory Authorities and the World Health Organisation are urging pharmaceutical companies to ...

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EMA COVID-19 assessments ‘OPEN’ to non-EU regulators

4 February 2021 - EMA is piloting a new ‘OPEN’ initiative to increase international collaboration on the evaluation of COVID-19 vaccines ...

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Extra transparency measures for COVID-19 vaccines and therapeutics

30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...

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EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines

5 October 2020 - The EMA has re-affirmed today that it will uphold its long-standing commitment to independence and transparency ...

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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...

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Documents disclosed to the EMA as part of an MA application process are not presumed to be confidential

28 January 2020 - On 22 January 2020 the CJEU handed down two decisions in which it decided that the ...

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Court of Justice upholds EMA’s approach to transparency

22 January 2020 - EMA welcomes today’s two appellate judgments by the Court of Justice that confirmed, in clear and ...

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EMA scales back transparency initiatives because of workload

14 August 2018 - The European Medicines Agency has scaled back its landmark clinical trial data policies, the drug regulator ...

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The need for transparency of clinical evidence for medical devices in Europe

11 August 2018 - To use medical devices rationally, health-care professionals must base their choices of which devices to recommend for ...

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General Court confirms EMA approach to transparency

6 February 2018 - Three rulings clarify the scope of commercial confidentiality with regard to authorised medicines ...

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Unparalleled access to clinical data - one year on

20 October 2017 - Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback. ...

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Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

26 July 2017 - Goldacre et al. set out to identify the policies of major pharmaceutical companies on transparency of trials, ...

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Call for experts in anonymisation of clinical data

23 March 2017 - EMA to set up technical group in the context of the publication of clinical data ...

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Release of documents on two medicines temporarily halted

14 March 2017 - EMA’s appeals against interim measures are dismissed by Court of Justice ...

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