EMA Streamlines Orphan Drug Process, Details Fee-Reduction Filings, Appeals

June 21, 2013
The European Medicines Agency May 8 released a guideline for orphan drug sponsors on how to file applications and request fee reductions under a new streamlined procedure. Drugmakers should notify the agency of their intent to submit an orphan drug application as early as possible, the agency says, adding that no later than two months prior to the planned submission date is preferred.
International Pharmaceutical Regulatory Monitor