The European Medicines Agency (EMA) and the Heads of Medicines
Agencies (HMA) of EU Member States have jointly released a draft
guidance document on information transparency related to marketing
authorization applications (MAAs). The document covers the types of
information included in MAAs that can be released to the public, and
that which is commercially confidential or protected personal data.
Stakeholders and the public may submit comments on the draft document
until 1 September.
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