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  • Regulatory NewsRegulatory News

    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Feature ArticlesFeature Articles

    ICH Q12 Post Approval Change Management Protocol: Advantages for Consumers, Regulators and Industry

    This article discusses the latest draft of ICH Q12 and significance of harmonizing regulatory requirements across regional borders. It emphasizes how Post-Approval Change Management Protocol (PACMP) can be used as a tool to improve strategic change management and ensure supply chain reliability. 1, 2 Introduction While the pharmaceutical industry is globalized, regulations are regionalized. This means a Marketing Authorization Holder (MAH) can manufacture a product a...
  • Regulatory NewsRegulatory News

    EMA-FDA QbD Pilot Program Led to Further Harmonization

    The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH). Background The joint pilot program, initially launched in March 2011 for three years, was extended for two more years in 2014 to facilitate further harmonization of per...
  • US, EU Regulators Extend QbD Pilot, Pledge Release of Further Quality Guidelines

    • 06 March 2014
    • By
    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have extended for another two years a pilot program that allows both agencies to simultaneously review quality-by-design (QbD) applications. Background The pilot program was first launched in March 2011 as a means by which both agencies could communicate review findings with respect to QbD elements of applications chosen for review. QbD refers to purposeful pharmaceutical development in which...
  • EMA, FDA Publish New Guidance on Adhering to Quality by Design Principles

    European regulators have announced that they, along with the US Food and Drug Administration (FDA), have released a second question-and-answer document intended to provide guidance to industry on the concept of "quality by design," or QbD. Background The QbD concept is well-known within most regulatory circles. Simply stated, it is the belief that quality should be designed-not tested-into the final product, including its manufacturing processes. In theory (and regulato...