5 items found

Tags: Drug Regulation

Filter Results
  • publication

    How long do new medicines take to reach Canadian patients after companies fil...

    Introduction Studies of the delay between when companies file a New Drug Submission (NDS) and when drugs reach Canadian patients typically focus on the time in the regulatory...
  • publication

    Industrial perceptions of medicines regulatory harmonization in the East Afri...

    Background Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale...
  • publication

    Oral Medicines for Children in the European Paediatric Investigation Plans

    INTRODUCTION: Pharmaceutical industry is no longer allowed to develop new medicines for use in adults only, as the 2007 Paediatric Regulation requires children to be considered...
  • publication

    Strategic Focus on 3R Principles Reveals Major Reductions in the Use of Anima...

    The principles of the 3Rs, Replacement, Reduction and Refinement, are being increasingly incorporated into legislations, guidelines and practice of animal experiments in order...
  • publication

    Gap analysis for drug development policy-making: An attempt to close the gap ...

    Introduction Most drug development policies in developing countries are enacted without achieving the desired results. This study aims to determine the prioritization of drug...