Research map: Regulatory harmonization: Evolution, globalization and future directions

Back to the article

Papers in this map

  1. The Magic of Randomization versus the Myth of Real-World Evidence · Rory Collins · 2020 · 489 citations · Cited by this paper
  2. Relationships among nitrous oxide exposure, neurological injury and biomarkers · 2026 · Related
  3. Double Standards, Scientific Methods, and Epidemiologic Research · Alvan R. Feinstein · 1982 · 170 citations · Cited by this paper
  4. Predicting cognitive function in Alzheimer's clinical trials via amyloid β‐protein biomarkers · 2026 · Related
  5. Use of Real‐World Evidence to Drive Drug Development Strategy and Inform Clinical Trial Design · Simon Dagenais · 2021 · 150 citations · Cited by this paper
  6. Comparative risk of ventricular arrhythmia and sudden cardiac death among acetylcholinesterase inhibitors in dementia: A population‐based cohort study · 2026 · Related
  7. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs · Bruce A. Feinberg · 2020 · 120 citations · Cited by this paper
  8. Pharmacogenomics of dolutegravir: A scoping review of evidence, gaps and clinical implications · 2026 · Related
  9. Randomized Trials vs Real-world Evidence · Radley Christopher Sheldrick · 2023 · 89 citations · Cited by this paper
  10. MT‐RNR1 genotype testing for preventing aminoglycoside‐mediated ototoxicity: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx) · 2026 · Related
  11. Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making · Elisabeth Bakker · 2022 · 84 citations · Cited by this paper
  12. Population pharmacokinetics and pharmacodynamics of canagliflozin in paediatric patients with type 2 diabetes mellitus · 2026 · Related
  13. The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics · David Charles Klonoff · 2019 · 77 citations · Cited by this paper
  14. Trends in publicly subsidized and private access to GLP‐1 medicines indicated for type 2 diabetes in Australia, 2020–2025 · 2026 · Related
  15. The Value and Benefits of the International Conference on Harmonisation to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health · Justina A. Molzon · 2011 · 57 citations · Cited by this paper
  16. Analysis of spontaneous reports of suspected adverse reactions related to medical cannabis from the Italian Phytovigilance System · 2026 · Related
  17. Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019 · Sini Marika Eskola · 2021 · 52 citations · Cited by this paper
  18. A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience · 2026 · Related
  19. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries · Carlos E. Durán · 2021 · 49 citations · Cited by this paper
  20. Country-specific regulation and international standardization of cell-based therapeutic products derived from pluripotent stem cells · Takamasa Hirai · 2023 · 41 citations · Cited by this paper
  21. Real-world evidence for regulatory decision-making: updated guidance from around the world · Leah C. Burns · 2023 · 41 citations · Cited by this paper
  22. Clinical Pharmacology Applications of Real‐World Data and Real‐World Evidence in Drug Development and Approval–An Industry Perspective · Rui Zhu · 2023 · 39 citations · Cited by this paper
  23. Inclusion of nonrandomized studies of interventions in systematic reviews of interventions: updated guidance from the Agency for Health Care Research and Quality Effective Health Care program · Ian Jude Saldanha · 2022 · 38 citations · Cited by this paper
  24. Future directions in regulatory affairs · Orin T. Chisholm · 2023 · 37 citations · Cited by this paper
  25. Best practices in the African Medicines Regulatory Harmonization initiative: Perspectives of regulators and medicines manufacturers · Margareth Ndomondo-Sigonda · 2023 · 36 citations · Cited by this paper
  26. Medicines Regulatory Harmonization: International Collaboration as a Key to Improve Public Health · Valerio Reggi · 2016 · 27 citations · Cited by this paper
  27. Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks · Thomas Desmet · 2024 · 25 citations · Cited by this paper
  28. International Conference on Harmonization: Recent Reforms as a Driver of Global Regulatory Harmonization and Innovation in Medical Products · Lenita Lindström‐Gommers · 2018 · 24 citations · Cited by this paper
  29. Reliance: a smarter way of regulating medical products - The IPRP survey · Petra Doerr · 2020 · 24 citations · Cited by this paper
  30. Reliance is key to effective access and oversight of medical products in case of public health emergencies · Agnès Saint-Raymond · 2022 · 19 citations · Cited by this paper
  31. The Impact of Additive Population(s), Intervention, Comparator(s), and Outcomes in a European Joint Clinical Health Technology Assessment · Anke van Engen · 2024 · 17 citations · Cited by this paper
  32. Advancing cooperation in Health Technology Assessment in Europe: insights from the EUnetHTA 21 project amidst the evolving legal landscape of European HTA · Luz Irene Urbina · 2024 · 17 citations · Cited by this paper
  33. Global harmonization in advanced therapeutics: balancing innovation, safety, and access · Ankit Dahiya · 2025 · 15 citations · Cited by this paper
  34. Regional regulatory harmonisation initiatives: Their potential contribution to the newly established African Medicines Agency · Nancy Ngum · 2023 · 14 citations · Cited by this paper
  35. A Brief Report on Proposed Areas of International Harmonization of Real‐World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators · Maryam Nafie · 2025 · 13 citations · Cited by this paper
  36. Strengthening Health Products Regulatory Systems to Enhance Access to Quality Health Products in the Asia-Pacific · John C. W. Lim · 2018 · 11 citations · Cited by this paper
  37. Stronger Food and Drug Regulatory Systems Abroad · Board on Global Health · 2020 · 11 citations · Cited by this paper
  38. Regulating Medicines in a Globalized World · Board on Global Health · 2019 · 11 citations · Cited by this paper
  39. Use of Real‐World Data and Real‐World Evidence in Rare Disease Drug Development: A Statistical Perspective · Jie Chen · 2025 · 11 citations · Cited by this paper

Source: OpenAlex (CC0)