Vol 13 No 4 (2025): VOLUME 13, ISSUE 4, 2025 | International Journal of Drug Regulatory Affairs

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Research

The protective effects of almond milk against hydrogen peroxide damage in Arpe-19 cell line and its biological effects

Gülçin ALP AVCI

Pages 57-61
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.825

Review

A Comparative Review of Fast-Track Generic Drug approvals: Criteria and Timelines across FDA, Swissmedic, MHRA, and PMDA

Sakshi Nagesh Deshmukh, Syed Shoaib Ali, Suchita Anand Shirole

Pages 1-18
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.794
Comparison and Registration Pathway of Nutraceuticals in Canada, India, Australia, Japan and South Korea

Nusrathunisha Sathik Fathimabeevi, Charumathi Panneerselvam, Saba Maanvizhi

Pages 19-25
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.813
Data Integrity in Pharmaceuticals

Madhanraj S, Anton Smith A

Pages 26-36
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.816
Post-Market Surveillance Evolution: Pharmacovigilance 2.0 and the future of global Drug Safety

Shanmugapriya Prabhu, Saba Maanvizhi

Pages 37-43
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.817
A Strategic Analysis of Work-Sharing: Access Consortium, Project Orbis, and Project Optimus

Jonali Ramani

Pages 44-47
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.818
Artificial Intelligence in Pharmaceutical Regulatory Affairs and Medical Science Liaison Activities: A Comprehensive Review

Sayashree Ananthan

Pages 52-56
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.820
Clinical Research Regulation in India and Brazil: An Overview of Current Frameworks and Implementation Gaps

Rohan Kailash Shinde, Lokesh P. Kothari

Pages 62-71
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.826
Management of Packaging Artwork Design for Medicines in the Pharmaceutical Industry: Standardised Labelling and Package Leaflet Requirements and their Assessment Process in the European Centralised Procedure

Rabab Abdo Mohamed Fadlelmula

Pages 81-90
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.831
Evolution of Clinical Trial Regulations in Cote D’Ivoire

Paule Mireille ALLOUKOU-BOKA, Anne-Cinthia AMONKOU-N’GUESSAN, Akadjé Richard ALLOUKOU, Marie France NANGUY, Aziz Flores KAMELAN, Franck Habib GAUZE, Antoine Serge AMARI

Pages 72-80
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.829

Case Study

From Reviewer to Consultant: Transforming Regulatory Affairs in the MDR Transition

Holger Wagner

Pages 48-51
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v13i4.819