Transparency: studies to be made publicly available
Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with EU ministers and passed by Parliament in April.
In negotiations, MEPs amended the draft to improve transparency, by requiring that detailed summaries be published in a publicly-accessible EU database, including full clinical study reports to be published once a decision on marketing authorisation has been taken or the marketing authorisation application has been withdrawn. Fines would be imposed on sponsors who do not comply with these requirements.
Read more on the European Parliament website.
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