The new legislation will modernise how medicines are developed, authorised and made available to patients across the EU. It is expected to simplify structures and procedures which have been introduced by different pieces of legislation over the years, namely the existing pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC) and the legislation on medicines for children and for rare diseases (Regulation 1901/2006 and Regulation 141/2000/EC, respectively). It also amends the advanced therapy medicinal products (ATMP) Regulation 1394/2007.

Key areas affected by the reform

The new pharmaceutical legislation will bring significant changes across multiple areas of EMA’s work.

Key elements include:

A simpler regulatory environment

• EMA will simplify its committee structure from five to two scientific committees for human medicines: the Committee for Human Medicinal Products (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC). The new, leaner…