EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy
The European Medicines Agency will be looking at reviving its policy on proactive publishing of clinical study reports, which is currently suspended as the agency copes with huge staff losses on account of Brexit.
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The reduction in the European Medicines Agency’s activities since the UK voted to leave the EU nearly three years has impaired the regulator's ability to keep up with scientific and regulatory developments, and it is facing more staff losses as a result of its relocation to the Netherlands. However, the agency says it has managed to safeguard its core activities relating to the evaluation and supervision of medicines, and that the EU regulatory network should be able to adapt to Brexit-related changes without jeopardizing the quality of its work.
The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.
The UK is on a mission to re-join the International Council for Harmonisation as a fully active member with voting rights.