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  • USP Releases Overhaul of Impurities Testing Standards

    • 24 May 2012
    The US Pharmacopeia (USP), a standards-setting body for the content of medicines, has released two new standards to limit the presence of elemental impurities in medicinal products. The standards, <232> Elemental Impurities - Limits and <233> Elemental Impurities - Procedures , outline procedures on how to detect common impurities and sets limits on the presence of impurities to protect consumers from exposure. "Elemental impurities can occur naturally, b...
  • EMA Launches New Board to Coordinate Committees' Scientific Standards

    The European Medicines Agency (EMA) announced the launch of a new Scientific Coordination Board (SCB) which is intended to coordinate the development and implementation of standards between its committees. The board, which was announced 25 April, aims to make it "so that the standards they set for the development of medicines are consistent across the whole product life-cycle, for increased robustness and predictability of benefit-risk assessment," EMA said in a statemen...
  • NICE Announces More Than 120 New Quality Standards

    The National Institute for Health and Clinical Excellence (NICE), the UK's care-rationing body, announced 22 March it is developing more than 120 new quality standards, dramatically increasing the number of standards in development. NICE currently has 15 published quality standards, and already has another 20 in development in addition to the 123 new proposed standards. The new standards will cover a wide range of diseases, conditions and habits, including pneumonia, mul...
  • Updated List of Recognized Medical Device Standards Released By FDA

    The US Food and Drug Administration (FDA) published an updated list of FDA-recognized medical device standards, aiming to "assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices." Under the 1997 Food and Drug Administration Modernization Act (FDAMA) , FDA is authorized to recognize consensus standards developed by national and international organizations. The list was last updated in August 2011, an...
  • New ISO/IEC Guide Addresses Medical Device Safety Regulations

    A new guide put forth by the International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) aims to address medical device safety by guiding the development of new safety standards. ISO/IEC Guide 63:2012,  Guide to the development and inclusion of safety aspects in international standards for medical devices , seeks to improve upon earlier ISO guides by promoting the "optimal use of resources" through limiting the development of...
  • CDER: Guidance on NDA/BLA/ANDA Data Standards Coming in Mid-2012

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) announced on 12 January that it is planning to release  new regulatory requirements by mid-2012 for electronic submissions of all study data included in New Drug Applications (NDAs), Biologics License Applications (BLAs) and Abbreviated New Drug Applications (ANDAs). The new regulatory requirements are a result of CDER's Data Standards Program, which is aims to create standar...