Editorial

20 September 2022

Editorial: Insights in Regulatory Science 2021

Bruno Sepodes

and

Peter Mol

1,737 views

2 citations

Editors

Bruno Sepodes

University of Lisbon

Peter GM Mol

University Medical Center Groningen

Impact

Review

21 June 2022

A VOSviewer-Based Bibliometric Analysis of Prescription Refills

Runchen Fu

, 5 more and

Yibo Wu

8,630 views

30 citations

Original Research

13 May 2022

METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials

Ki Young Huh

, 8 more and

Min-Gul Kim

3,880 views

16 citations

Policy and Practice Reviews

10 May 2022

20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

Gabrielle M. O’Sullivan

, 3 more and

John E. J. Rasko

16,211 views

7 citations

Brief Research Report

26 April 2022

Biomarkers in Medicines Development—From Discovery to Regulatory Qualification and Beyond

Natalie M. Hendrikse

, 3 more and

Falk Ehmann

8,228 views

19 citations

Policy Brief

15 April 2022

Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan

Hideki Maeda

and

Daniel Bin Ng

10,951 views

8 citations

Original Research

30 March 2022

Perceptions of Regulatory Decision-Making for New Drugs From the Viewpoints of the Manufacturers in South Korea

Kyung-Bok Son

and

Sylvia Park

3,266 views

2 citations

Original Research

09 March 2022

Regulatory Information and Guidance on Biosimilars and Their Use Across Europe: A Call for Strengthened One Voice Messaging

Liese Barbier

, 4 more and

Isabelle Huys

15,078 views

32 citations

Policy and Practice Reviews

03 February 2022

Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness

Melanie McPhail

, 1 more and

Tania Bubela

9,077 views

12 citations

Perspective

13 January 2022

The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective

Hideki Maeda

13,010 views

11 citations

Perspective

12 January 2022

Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities

Orin Chisholm

, 1 more and

Lawrence Phillips

10,548 views

21 citations

Perspective

09 December 2021

Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

Jorn Mulder

, 9 more and

Anna M. G. Pasmooij

6,312 views

3 citations

Policy and Practice Reviews

23 November 2021

A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines

Heraclio Rodriguez

and

Maria Lucia De Lucia

5,243 views

3 citations

Original Research

01 November 2021

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency

Laura Patricia Orellana García

, 3 more and

Angela Brand

17,249 views

24 citations

Brief Research Report

11 October 2021

Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity

Ai Fukaya-Shiba

, 3 more and

Rika Wakao

6,071 views

3 citations

Policy and Practice Reviews

27 August 2021

Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

Maria E. Sheean

, 12 more and

Violeta Stoyanova-Beninska

6,700 views

6 citations

Review

25 August 2021

Implementation and Access to Pre-exposure Prophylaxis for Human Immunodeficiency Virus by Men Who Have Sex With Men in Europe

Bruno Sepodes

, 4 more and

Carla Torre

52,228 views

7 citations

Policy and Practice Reviews

11 August 2021

Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

Jeanne-Céleste Paquet

, 6 more and

Alice Rouanet

23,959 views

37 citations

Original Research

31 May 2021

Evaluation of Consistency of Treatment Response Across Regions—the LEADER Trial in Relation to the ICH E17 Guideline

Henrik K. Nielsen

, 1 more and

Bryan Goldman

4,147 views

7 citations

Original Research

31 May 2021

Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model

Meng Li

, 8 more and

Carolina Oi Lam Ung

50,443 views

46 citations

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