ARTICLE | Regulation

EMA's expanded transparency

Drug industry not alarmed by EMA's expanded document disclosure policy

December 6, 2010 8:00 AM UTC

EMA's new policy on providing public access to documents, including company marketing applications, is intended to increase the transparency of its decision-making process. But industry stakeholders and legal experts contacted by BioCentury predicted the policy won't result in the disclosure of confidential commercial information and won't change current practice very much.

In principle, all documents of EU institutions and agencies have been accessible by the public since regulation (EC) No 1049/2001 entered into force in 2001. In 2006, the EMA adopted rules for implementing that regulation. Those rules and regulations include exceptions that allow the agency to refuse access to documents if disclosure would undermine protection of commercial interests and personal data...