International Generic Drug Regulators Programme (IGDRP)

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The European Medicines Agency (EMA) participates in the International Generic Drug Regulators Programme (IGDRP), which promotes regulatory collaboration and convergence to achieve greater regulatory efficiency and address challenges posed by globalised production and distribution chains and increasingly sophisticated generic products.

 Collaboration through the IGDRP aims to:

  • ensure timely patient access to high quality generic medicines;
  • increase regulatory efficiency through the sharing of assessments and quality and safety information;
  • enhance global regulatory harmonisation of assessments of generic medicines.

For participating agencies and organisations, see IGDRP: About us.

EMA role

From January 2015, EMA has been running a pilot for sharing its assessments of generic medicines with participating regulatory agencies outside the European Union (EU), as part of the IGDRP information-sharing iniative

This is an extension of the IGDRP pilot set up in in July 2014 using the EU's decentralised procedure as a model for sharing information on the scientific assessment of generic medicines.

The objective is to provide:

  • a more efficient and consistent review process;
  • reducing regulatory burden;
  • facilitating the similar timing of market authorisations in different regions of the world.

For more information and eligibility criteria, see:

EMA also participates in the quality working group and bioequivalence working group of the IGDRP.

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