EMA Draft Policy Calls for ‘Considered Approach’ on Trial Transparency

The European Medicines Agency last month unveiled its proposed policy for increasing access to clinical trial data, offering a “considered approach” to transparency that respects patient and commercial interests. The agency is giving stakeholders three months to comment on the plan, which would require that trial data be published in tandem with regulatory decisions about drug candidates, irrespective of whether they are approved, rejected or withdrawn.
International Pharmaceutical Regulatory Monitor