Access to documents held by EMA: access requests by non-EU applicants to cease
Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations
Updated EMA guidance on centrally authorised medicines raises new considerations for Brexit preparations
EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit
FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information
The EU Court of Justice dismisses EMA’s appeals in interim measures and suspends the release of clinical study report to third parties
EMA public consultation on revised policy on access to documents
EU – US mutual recognition of GMP inspections: agreement published
EMA pilot project on tailored scientific advice to support new biosimilars
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