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  • Regulatory NewsRegulatory News

    IPRF and IGRP Merge to Become the International Pharmaceutical Regulators Programme

    With an aim toward better exchanging information and avoiding duplication, the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) initiatives will merge as of the first of next year and be known as the International Pharmaceutical Regulators Programme (IPRP), according to notes from the IPRF's management committee meeting in Geneva on 12-13 November. The first face-to-face meeting of IPRP's management co...
  • Regulatory NewsRegulatory News

    IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018

    The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018. According to a summary of the 5th meeting of the IGDRP in Ottawa in June, the IPRF management committee and the IGDRP steering committee expressed support for the consolidation of the IPRF and IGDRP initiatives in order to best respond to ...
  • Regulatory NewsRegulatory News

    Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars

    The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars. Background The IPRF was created as a safe harbor for discussion and promotion of harmonization among regulatory authorities and Regional Harmonization Initiatives (RHIs), including 11 regula...
  • Regulatory NewsRegulatory News

    US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences

    US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week. Background Both governments' efforts come from a 2012 regulatory initiative known as the Regulatory Cooperation Council (RCC), whose stated goal is to increase regulatory cooperation between both countries. That cooperation, ...