The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has released the minutes of its most recent monthly meeting. The meeting was held 20th to 23rd March 2017.
The minutes contain details of pre-authorisation procedure oral explanations, initial applications and their first list of questions (Day 120; Day 90 for procedures with accelerated assessment timetable), those with lists of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) and those with positive opinions.
The minutes also include information on extension of marketing authorisation applications, Type II variations of therapeutic indications, pre-submission requests for accelerated assessment, PRIME eligibility requests, post-authorisation issues and referrals.
There were no discussions reported this month on ancillary medicinal substances in medical devices or procedures under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use).
Click here to access the meeting minutes.