Vol 14 No 1 (2026): VOLUME 14, ISSUE 1, 2026 | International Journal of Drug Regulatory Affairs

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Research

Between Statutes and Practice: Regulatory Capacity for Clinical Trials in The Gambia within the ECOWAS Regional Context

Abdoulie Bojang

Pages 6-11
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.843

Review

The BIOSECURE Act: Key implications for U.S. Biotechnology, National security, and Federal funding

Bobby George

Pages 1-5
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.840
Comprehensive Comparison of Clinical Trial Protocol & Clinical Investigation Plan in Different Countries

Sedamaki Chaitanya, Dhulipudi Hara Naga Ganesh, Rudra Vaishno, Prasanthi D.

Pages 12-20
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.844
Regulation of the pharmaceutical industry in Côte d'Ivoire and alignment with community development policies: realities and prospects for 2025

Anne-Cinthia AMONKOU - N'GUESSAN, Paule Mireille ALLOUKOU - BOKA, Fatima GUIET MATI, Aziz Flores Dominique KAMELAN, Franck Habib GAUZE, Antoine Serge AMARI

Pages 21-32
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.848
Global Regulatory Frameworks for Drug Approval: A Comparative Review of USFDA, EMA, and CDSCO

Anand Mane, Sudarshan Nagrale

Pages 33-41
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.852
Electronic Common Technical Document (eCTD): Structure, Submission Process, and Regulatory Updates

Pravin Salunkhe, Sudarshan Nagrale

Pages 42-50
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.854
Regulatory Affairs in Clinical Trials: Ethical, Legal, and Compliance Considerations

Rutuja Vijaykumar Pradnyawant, Sudarshan Nagrale

Pages 51-60
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.857
Pharmaceutical Regulatory Intelligence: Tools, Strategies, and Impact on Product Lifecycle Management

Sonam Shamrao Nimbalkar, Sudarshan Nagrale

Pages 61-70
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.858
Reinventing Drug Development and Regulatory Affairs through Artificial Intelligence

Almas Nafis Shaikh, Shoaib Ali Syed

Pages 71-77
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.860
Regulatory Requirements for Participation in WHO Prequalification Programme for Parenteral Products

Aditi Muskan Jha, Maitrey Zaveri, Shirish Patel, Zuki Patel

Pages 78-84
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.864
Bridging Regulatory Speed: A US–EU Perspective on Rapid Drug Approvals

Nidhi Anilsingh Bhadauria, Maitreyi Zaveri, Shirish Patel, Zuki Patel

Pages 85-90
- View pdf Abstract Download pdf DOI 10.22270/ijdra.v14i1.872