EMA To Discuss Reactivating Landmark Clinical Trials Transparency Policy
Executive Summary
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.
You may also be interested in...
EMA Chief Says Brexit Has Impaired Ability To Support R&D
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.
Brexit Bites EMA: Huge Staff Losses Freeze Many Projects
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.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.