Publications by authors named "Magda Bujar"

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Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach.
Noraisyah Mohd Sani, Siti Hidayah Kasbon, Kian Yee Yap, Muhamad Firdaus Abdullah, Rosliza Lajis, Magda Bujar

Ther Innov Regul Sci· November 2025

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Harmonizing health: a global analysis of pharmaceutical regulatory activities by international regulatory organizations.
Agnes Dangy-Caye, Alice Mousset, Adem Kermad, Louise Bouché-Bazerolle, Magda Bujar

Front Med (Lausanne)· October 2025

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An Evaluation of the Swissmedic Regulatory Framework for New Active Substances.
Magda Bujar, Simon Andreas Dalla Torre di Sanguinetto, Adem Kermad, Claus Bolte, Neil McAuslane

Ther Innov Regul Sci· January 2024

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A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration.
Ulrich-P Rohr, Mario Iovino, Leonie Rudofsky, Qiyu Li, Stephanie Juritz, Magda Bujar

Clin Transl Sci· September 2023

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Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening.
Jane Mashingia, Nancy Ngum, Margareth Ndomondo-Sigonda, Adem Kermad, Magda Bujar

Regul Toxicol Pharmacol· May 2023

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Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities.
Neil McAuslane, Magda Bujar, Tariro Sithole, Nancy Ngum, Mercy Owusu-Asante

Pharmaceut Med· May 2023

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Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?
Magda Bujar, Sara Ferragu, Neil McAuslane, Lawrence Liberti, Thomas C Kühler

Clin Ther· May 2021

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Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice.
Céline Rodier, Magda Bujar, Neil McAuslane, Prisha Patel, Lawrence Liberti

Ther Innov Regul Sci· January 2021

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To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
Thomas Christian Kühler, Magda Bujar, Neil McAuslane, Lawrence Liberti

BMJ Open· November 2019

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FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines.
Lawrence Liberti, Magda Bujar, Alasdair Breckenridge, Jarno Hoekman, Neil McAuslane

Front Pharmacol· April 2017

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