Pharma Opposes 'Harmful' Changes To EMA’s Access To Documents Policy
The EU pharmaceutical industry has concerns about the European Medicines Agency’s proposal to grant extended access to documents on orphan designations and pediatric investigation plans under its revised access to documents policy. The changes would discourage innovation and lead to inadvertent disclosure of commercially sensitive data, companies claim.
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The EU court’s dismissal of appeals filed by the European Medicines Agency in cases relating to its access to documents policy means stakeholders will have to wait even longer to get legal clarity on the policy. One lawyer believes that the case could result in a broader definition of what constitutes commercially confidential information.
The European Medicines Agency is inviting feedback on changes to its policy on access to documents to clarify that it also covers the agency’s corporate documents.
The European Medicines Agency’s plan to publish details of the studies and measures it agrees with a drug developer for a pediatric investigation plan will help other companies in framing their future marketing authorization applications. But there are concerns that the agency's plan might result in the disclosure of commercially confidential information.