The European Medicines Agency (EMA) has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications. The guideline identifies which parts of an application dossier can or cannot be released in response to document requests.
According to the EMA, the guidance is a "major step for transparency" when dealing with requests for access to marketing authorization applications and is the first time that a harmonized, European approach to the issue has been adopted. Going forward, all regulatory authorities in the European Economic Area will apply the same principles.
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