Working towards harmonised access to clinical trial data across European drug regulatory agencies

BMJ

31 July 2021 - On 31 May 2021, a group of researchers and NGOs submitted an open letter to the Heads of Medicines Agencies, a European umbrella organisation consisting of the heads of the national drug regulatory agencies, proposing them to harmonise access to clinical trial data across European drug regulatory agencies.

During 2018 and 2019, independent researchers approached several European national drug regulatory agencies and requested access to documents related to clinical trials of ADHD medications and statins for use in systematic reviews.

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Michael Wonder

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Michael Wonder

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Europe , Clinical trial , Data