EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.