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Generics regulators outline priorities to 2020 Posted 27/01/2017

The International Generic Drug Regulatory Programme (IGDRP) announced on 21 December 2016 that it had released its ‘Roadmap to 2020’, which outlines the group’s priorities until 2020. The document outlines those priorities as including five initiatives geared toward harmonizing global regulations for generics.

The IGDRP was created in 2011 to promote collaboration and convergence of generic drug regulators in order to address challenges posed by increasing workloads, globalization and complexity of scientific issues [1]. The organization includes drug regulators such as the Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, the Chinese FDA and Japan’s Ministry of Health. Among other objectives, the IGDRP initiative has the ambition to increase efficiency of review procedures and reduce regulatory burden without comprising the safety, efficacy, and quality of generics.

In its roadmap, the IGDRP describes how its priorities include:

  • Establishing a framework for sharing assessment-related information for generics between regulators
  • Promoting greater regulatory convergence of technical and data requirements for generics applications based on international standards and best practices
  • Increasing alignment of administrative and regulatory assessment procedures and tools, e.g. assessment templates, terminologies
  • Creating conditions and developing enablers, e.g. IT tools, databases, to facilitate greater inter-agency collaboration, communication and training
  • Creating and enabling opportunities for communication and engagement with stakeholders

In order to achieve its priorities, the IGDRP will use lessons learned, ongoing pilot information, develop and assess regulatory tools in working groups, and conduct surveys designed to develop reference materials to summarize the similarities and differences in standards among the drug regulators and identify potential regulatory convergence points.

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1.    GaBI Online - Generics and Biosimilars Initiative. EMA to collaborate with other agencies on generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jan 27]. Available from: www.gabionline.net/Policies-Legislation/EMA-to-collaborate-with-other-agencies-on-generics

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Source: IGDRP

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