Blogs

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European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) of EU Member States have jointly released a draft guidance document on information transparency related to marketing authorization applications (MAAs).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.

Read more:

• EMA, Heads of Agencies consult on confidential info issues (Pharma Times)
• EMA/HMA set drug application guidance (PMLive)
• European Medicines Agency and Heads of Medicines Agencies propose measures to make information in application dossiers more transparent (EMA press release)