EU Proposes To Chop EMA Committees, Drop Five-Year Renewals

The EMA, Not The Commission, Would Decide On Orphan Designation

The EU’s legislative revision proposals include stripping down the European Medicines Agency’s committee structure, abolishing the five-yearly marketing authorization renewal requirement, and doing away with the “sunset clause” that requires a product to be launched in at least one EU country within three years of approval.

EUFlagPills — The EU has big plans in hand for medicines regulation • Source: Shutterstock

Among the many wide-ranging proposals for the overhaul of the EU medicines legislation that are due to be published at the end of this month is a radical restructuring at the European Medicines Agency that will see the number of its scientific committees reduced from six to two.

The two committees that would remain are the Committee on Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk...