Accelerated assessment definition

Many countries offer a regulatory pathway that will expedite the evaluation of certain medicinal products so that they reach patients faster. In the EU, the accelerated assessment procedure reduces the timeframe for the European Medicines agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing authorisation (MA) application from 210 to 150 evaluation days. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation. In the UK, the Medicines and Healthcare Regulatory Agency (MHRA) offers a 150-day assessment timeline for all high-quality new MA applications in an effort to accelerate the availability of new medicines for patients in the UK. The MHRA evaluates the application for a UK, Great Britain (England, Wales and Scotland) or Northern Ireland MA and reaches its opinion on whether to approve the licensing of new medicines within 150 days of submission of a valid application. See also: marketing authorisation (MA).