FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

International Generic Drug Regulators Program Unveils Regulatory Priorities

Jan. 17, 2017
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The International Generic Drug Regulatory Program has outlined the group’s priorities for the next four years, focusing on five initiatives geared toward harmonizing global regulations on generic drugs.

The organization — comprising drug regulators such as the FDA, the EMA, Health Canada, the Chinese FDA and Japan’s Ministry of Health — intends to continue working toward establishing a framework for sharing the assessment information of generics among regulators by proceeding with its pilot program, launched in 2012,  that explored intra-agency opportunities for collaboration and information-sharing. It specifically plans to further develop collaborative agreements between IGDRP members that support generic approvals.

Aligning the technical and data requirements for generic drug applications based on international standards and best practices is among the top priorities as well. To do this, IGDRP will 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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