RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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
    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...
  • EMA, FDA Provide First Glimpse into Quality by Design Parallel Assessment Pilot

    US and EU regulators have announced the release of a new joint question and answer document meant to provide insight into the first-ever parallel assessment of a marketing authorization application by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Background The pilot program was first launched in March 2011 as a means by which both agencies could communicate review findings with respect to quality-by-design (QbD) elements of applicat...