CHMP: Committee for Medicinal Products for Human Use

The Committee for Medicinal Products for Human Use is established by Article 5 of Regulation (EC) No 726/2004. It is responsible for formulating the Agency's opinion on any question about the admissibility of applications submitted through the centralised procedure, the grant, variation, suspension or withdrawal of a centralised marketing authorisation, and pharmacovigilance for those products. It also gives opinions in referral procedures under Directive 2001/83/EC and scientific opinions under Article 5(3) of the Regulation on questions put to it by the Commission or a Member State.

Each Member State nominates one member and one alternate, Iceland and Norway take part, and the committee can co-opt up to five further members for specific expertise. For every application the committee appoints a rapporteur and a co-rapporteur from among its members, who lead the assessment with their national agencies and present their reports for discussion at the monthly plenary meeting. Opinions are adopted by consensus where possible and otherwise by absolute majority, with divergent positions recorded.

The committee works to the published timetable of the centralised procedure: list of questions at Day 120, list of outstanding issues at Day 180, opinion by Day 210. Its working parties, including the Scientific Advice Working Party and the quality, safety and biologics working parties, prepare guidelines and give expert input. The outcome of each assessment is published as a European public assessment report once the Commission has decided.

What goes wrong: applicants who learn of a major objection only at Day 120 because they never asked for scientific advice; responses that answer the rapporteur's wording rather than the underlying concern, so the objection returns at Day 180; and teams that miss the meeting calendar, when a response submitted a day after the deadline waits a month for the next plenary. A negative opinion can be re-examined, but only on the grounds already on file, and the applicant may ask for different rapporteurs and for consultation of a scientific advisory group. Applicants who withdraw before the opinion to avoid a refusal find that EMA publishes a withdrawal assessment report and a question and answer document, so the concerns become public either way.