CHMP

Also known as: Committee for Medicinal Products for Human Use

The EMA committee that issues opinions on whether a medicine should be authorised in the EU.

Definition

The Committee for Medicinal Products for Human Use (CHMP) is the scientific committee of the EMA that prepares opinions on the authorisation, refusal, withdrawal, or variation of medicines under the centralised procedure. A positive CHMP opinion is typically followed by a European Commission decision within ~2 months.

See also

• EMA — The EU regulatory agency that authorises and supervises medicines for use across member states.
• EPAR — The publicly available EMA assessment of a centrally-authorised medicine.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval