BioCentury
ARTICLE | Politics & Policy

EMA revises accelerated assessment, conditional approval guidelines

July 28, 2015 2:53 AM UTC

EMA issued draft revisions of its accelerated assessment and conditional approval guidelines.

The accelerated assessment guideline now includes a more detailed explanation of how applicants may justify "major public health interest," the basis for the pathway. The document also revises the pre-submission timetable to encourage sponsors to engage in early dialogue with EMA. Sponsors would now have to indicate their intent to apply for accelerated approval six to seven months before submitting a marketing application, then submit the request two to three months rather than 10-30 days ahead of an MAA submission. The EMA's CHMP will also optimize its timetable to reach a decision within 150 days. ...