CTA

Also known as: Clinical Trial Application

The EU equivalent of the US IND — required to begin clinical trials in member states.

Definition

A Clinical Trial Application (CTA) is the submission required to start a clinical trial in EU member states. Under the EU Clinical Trials Regulation 536/2014 (in force since Jan 2022), CTAs are submitted via the Clinical Trials Information System (CTIS) and assessed jointly by all participating member states.

See also

• IND — The FDA authorisation required before testing an experimental drug in humans.
• EMA — The EU regulatory agency that authorises and supervises medicines for use across member states.

Other regulatory terms

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