Regulatory Roundup: EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

Dec 02, 2010
By PharmTech Editors

In European regulatory news, the European Medicines Agency (EMA) published a new policy this week regarding public access to its documents about drugs for human and veterinary use. The policy is part of EMA’s response to increasing public demand for more openness and transparency, according to a release from the agency. FDA launched the first phase of its transparency initiative early this year. The specifics of EMA’s plan include releasing documents concerning drugs after a procedure has been finalized, giving access to all business-related documents (unless there is a need to respect other privacy arrangements), and releasing non-confidential sections of documents submitted to the agency as part of a marketing authorization application such as clinical-trial reports (after the application has been finalized, that is). Any information that is confidential within marketing applications will be redacted to protect personal and commercial data. The new policy will be implemented in two phases, the first being the reactive disclosure of documents in response to written requests.

EMA also released a draft guideline last week on similar biological medicinal products containing monoclonal antibodies. The guideline specifies requirements for medicines containing mAbs that claim to be similar to another such medicine already marketed. Comments on the draft are due May 31, 2011.