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About this Journal

This journal focuses specifically on how pharmaceutical regulatory science can be applied to enhance product quality and availability.

Regulatory science came to the forefront when in 2010 the FDA defined it as:

‘the science of developing new tools, standards, and approaches to assess the quality, safety and efficacy of drug products’.

This confirmed the relevance of the ongoing research activity being carried out by the Pharmaceutical Regulatory Science Team (PRST) at TU Dublin, which since 2005 engaged with global industry and regulators to develop patient-focused strategies, frameworks, models and tools which enable those involved in the manufacture of medicines meet the evolving international regulatory expectations ensuring the availability of high-quality products.

In 2020, The European Medicines Agency (EMA) launched the ‘Regulatory Science to 2025' strategy and in its interim report in 2023, it noted that:

‘Regulatory science refers to the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools.’

This 2023 EMA description of regulatory science, when applied to the commercial / manufacturing phase of a product lifecycle, conveys the essence of the types of articles this journal seeks to publish. The editors encourage articles which are the result of collaborations between industry, academia and regulatory agencies.

Specifically, relevant topics which the editors envisage would nominally include:

  • Quality Risk Management (QRM)
  • Knowledge Management (KM)
  • Decision Making
  • Quality Metrics
  • Pharmaceutical Quality System (PQS)
  • Post-Approval Changes (PAC)
  • ICH Quality Guidelines (e.g., Q8, Q9, Q10, Q12)
  • PIC/S Guidelines
  • Quality Culture
  • Product Availability / Drug Shortages
  • Operational Excellence (OpEx), Cultural Excellence & Continuous Improvement
  • Advanced manufacturing strategies
  • Digitalisation and AI