The European Union’s decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators Pilot.
The EU is currently leading an international pilot project through which it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU. The EU aims to reinforce collaboration and information-sharing between regulatory authorities across the world, contributing to facilitating and strengthening the scientific assessment process for medicines. According to the EMA, the European Medicines Agency, this should enable medicines to be authorised in different territories in a coordinated way at approximately the same time.
The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland.