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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

    IGDRP Offers Guidance for Quality Assessors on Drug Substances

    The International Generic Drug Regulators Programme (IGDRP) on Tuesday released guidance finalized in June to help regulatory agencies’ quality assessors review technical information on active substances. Initially drafted by regulators from Australia, Canada, Singapore and Switzerland, the document provides assistance to quality assessors in reviewing the technical information contained in the Quality Module (Module 3) of Active Substance Master Files (ASMFs)/Drug...
  • 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

    International Generic Drug Regulators Unveil New Biowaiver Assessment Template

    Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members. IGDRP, which is made up of regulators from all over the world including the US Food and Drug Administration, Health Canada, European Medicines Agency and China Food and Drug Administration, among others, created its Bioequivalence Working G...
  • Regulatory NewsRegulatory News

    EMA to Share Information About Generic Drugs With Other Regulators

    The European Medicines Agency (EMA) has announced it is ready to begin sharing its assessments of generic drugs as part of an ongoing pilot with participating regulatory authorities. The goal of the pilot program, known as the International Generic Drug Regulators Pilot (IGDRP), is to bolster collaboration with regulators around the world and address the challenge of assessing generic drug applications. Background In October 2011, regulatory authorities from Australia...