International Journal of Drug Regulatory Affairs

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

Bobby George — Sun, 15 Mar 2026 00:00:00 -0400

The BIOSECURE Act is aimed at ensuring that U.S. taxpayer money isn’t going to fund biotech-aligned companies that can threaten national security. Specifically, the legislation prohibits federal contracting with companies tied to “foreign adversaries.” The legislation is a continuation of an earlier version that clearly targeted few key Chinese biotech firms. The law has laid out the process through which companies can be designated or exempted with an appeal process also provided. While the law does not name specific biotechnology companies of concern, the focus remains on some of Chinese entities. There will be pressure on U.S. companies to do reshoring of their manufacturing capabilities and adopt a China plus one strategy. The legislation also provides an opportunity for contract manufacturers/CDMOs including those from India, to make inroads in the U.S. market. Companies need strong cross-functional coordination and flexible strategies to maintain market access and resilience.

Conclusion: In the post-BIOSECURE environment, firms must comply with the Act’s restrictions while also identifying and taking advantage of new opportunities it creates.

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

Abdoulie Bojang — Sun, 15 Mar 2026 00:00:00 -0400

The global expansion of clinical research has heightened the importance of strong national regulatory systems capable of ensuring ethical conduct, scientific validity, and participant safety. While West Africa has become an increasingly important region for clinical trials, regulatory capacity across the region remains uneven, and small states such as The Gambia are underrepresented in regulatory scholarship. This desk-based review assesses the regulatory capacity for clinical trial oversight in The Gambia through a comparative analysis within the ECOWAS region. Drawing on national legislation, regulatory guidelines, regional harmonisation frameworks, and international benchmarking tools, the study examines legal authority, institutional capacity, approval processes, ethics oversight, and pharmacovigilance systems. Comparative insights from Ghana, Nigeria, and Senegal highlight both shared challenges and divergent regulatory trajectories. The analysis shows that although The Gambia has established foundational regulatory frameworks aligned with international standards, significant operational and capacity-related gaps persist. The study underscores the importance of regulatory reliance, regional harmonisation, and targeted capacity strengthening in advancing regulatory readiness in small regulatory systems.

Conclusion: This review demonstrates that strengthening regulatory readiness in The Gambia will depend less on new legislation and more on institutional capacity development, regional collaboration, and effective use of reliance mechanisms. Addressing these priorities is essential to safeguarding research participants and enhancing the country’s role in global clinical research.

Comprehensive Comparison of Clinical Trial Protocol & Clinical Investigation Plan in Different Countries

Chaitanya Sedamaki , Hara Naga Ganesh Dhulipudi, Vaishno Rudra, Prasanthi D. — Sun, 15 Mar 2026 00:00:00 -0400

Clinical research involving investigational medicinal products and medical devices is governed by region-specific regulatory frameworks that define the planning, review, and conduct of studies. The clinical trial protocol (CTP) and clinical investigation plan (CIP) serve as core regulatory documents required for approval and oversight. This review compares regulatory requirements for CTPs and CIPs in India, the United States, and the European Union, with a focus on definitions, structure, submission pathways, ethical considerations, and regulatory oversight. Across all regions, strong emphasis is placed on participant safety, scientific rationale, and compliance with good clinical practice. Common elements include study background, objectives, methodology, risk assessment, and data management. However, differences exist in terminology, approval processes, and region-specific expectations, particularly for medical device investigations and risk classification. Understanding both harmonised principles and jurisdiction-specific requirements can support regulatory compliance and facilitate efficient planning of multinational clinical research studies.

Conclusion: Despite differences in terminology, approval pathways, and regulatory authorities, a clear understanding of both global standards and region-specific requirements is essential for ensuring regulatory compliance and enabling efficient multinational clinical research.

Regulation of the Pharmaceutical Industry in Côte d'Ivoire and alignment with community development policies: realities and prospects for 2025

Sun, 15 Mar 2026 00:00:00 -0400

The Regional Pharmaceutical Plan of ECOWAS (PPRC) was adopted in 2014 by to address the insufficient development of local pharmaceutical industry (IP) with a desired impact to be seen by 2025. We appreciated the level of adequacy of the political and regulatory measures taken in Côte d’Ivoire, one Member State, to implement it. The Government recently identifies the PI cluster among the three priority since the five-year term 2021-2025. Various plans, but only a specific one, exist in Côte d’Ivoire in line with the desired industrialization. As for the specific legal framework, it hasn’t undergone much change since 2014. Nevertheless, in terms of institutional governance, a service dedicated to its promotion has been created into the Ministry of Health by Ministerial Order in April 2025.

Conclusion: There is a certain adequation between policies, regulatory and PPRC as well as good perspectives. That must be optimized in a global industrialization plan and the adoption of texts allowing it.

Global Regulatory Frameworks for Drug Approval: A Comparative Review of USFDA, EMA, and CDSCO

Anand Mane, Sudarshan Nagrale — Sun, 15 Mar 2026 00:00:00 -0400

The drug approval process is a critical regulatory functiorilen designed to ensure that medicinal products entering the market meet established standards of safety, efficacy, and quality. In an increasingly globalized pharmaceutical environment, understanding variations in regulatory frameworks across major jurisdictions is essential for effective drug development and regulatory strategy. Regulatory authorities such as the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the Central Drugs Standard Control Organization (CDSCO) play pivotal role in shaping global drug approval practices. This review provides a comprehensive comparative analysis of the regulatory frameworks governing drug approval in the United States, European Union, and India. Key aspects examined include organizational structures, approval pathways, submission requirements, review timelines, accelerated approval mechanisms, benefit–risk assessment approaches, and post-marketing surveillance systems. Information was compiled from official regulatory guidelines, international harmonization documents, and peer-reviewed literature to ensure accuracy and relevance. The analysis reveals that while USFDA and EMA operate through highly structured and transparent regulatory systems with well-defined accelerated pathways, CDSCO has made significant progress in aligning its regulatory processes with international standards through adoption of ICH guidelines and regulatory reforms. Nonetheless, differences persist in approval timelines, documentation requirements, and post-authorization obligations, which may influence global drug development strategies. Overall, continued regulatory harmonization, reliance-based approaches, and international collaboration are essential to streamline approval processes and enhance patient access to innovative therapies. This review offers valuable insights for regulatory professionals, researchers, and postgraduate students involved in global regulatory affairs and pharmaceutical development. Overall, while USFDA and EMA demonstrate mature, highly structured regulatory systems with well-established expedited pathways, CDSCO is rapidly evolving through regulatory reforms and ICH alignment. Persistent differences in timelines, documentation, and post-authorization requirements continue to influence global development strategies. Strengthened regulatory harmonization, reliance mechanisms, and international collaboration remain essential to accelerate patient access to safe and effective medicines worldwide.

Conclusion: Drug approval frameworks in the US, EU, and India aim to ensure safe and effective medicines, though differences exist in regulatory processes and timelines. While USFDA and EMA represent mature regulatory systems, CDSCO is rapidly advancing through regulatory reforms and ICH harmonization. Greater global collaboration and regulatory alignment are essential to improve efficiency and accelerate patient access to innovative therapies.

Electronic Common Technical Document (eCTD): Structure, Submission Process, and Regulatory Updates

Pravin Salunkhe, Sudarshan Nagrale — Sun, 15 Mar 2026 00:00:00 -0400

The Electronic Common Technical Document (eCTD) has become a cornerstone in modern pharmaceutical regulatory submissions, offering a standardized, modular, and digital framework for dossier preparation and review. By integrating structured modules, XML backbone files, hyperlinks, and lifecycle management features, eCTD enhances efficiency, traceability, and compliance across multiple regulatory authorities. This review provides a comprehensive overview of eCTD, detailing its structure, submission process, regional variations, and recent regulatory updates, including the adoption of eCTD v4.0. The manuscript also examines practical insights from industry case studies, highlighting successful global submissions and lessons learned for post-approval lifecycle management. Challenges associated with eCTD implementation, such as technical complexities, regional disparities, data integrity concerns, and operational constraints, are critically discussed. Emerging trends, including artificial intelligence, automation, cloud-based platforms, and blockchain technology, are explored for their potential to improve submission accuracy, reduce review timelines, and enhance regulatory predictability. The review emphasizes the strategic role of eCTD not only as a compliance tool but also as a driver of efficiency, global harmonization, and informed decision-making in regulatory affairs. Understanding these aspects is essential for regulatory professionals, enabling optimized submission workflows and improved management of the pharmaceutical product lifecycle. Overall, eCTD has evolved from a regulatory submission format into a strategic enabler of efficiency, transparency, and global harmonization. Continued adoption of advanced digital technologies will further strengthen lifecycle management and regulatory decision-making.

Conclusion: Overall, eCTD has evolved from a regulatory submission format into a strategic enabler of efficiency, transparency, and global harmonization. Continued adoption of advanced digital technologies will further strengthen lifecycle management and regulatory decision-making.

Regulatory Affairs in Clinical Trials: Ethical, Legal, and Compliance Considerations

Rutuja Vijaykumar Pradnyawant, Sudarshan Nagrale — Sun, 15 Mar 2026 00:00:00 -0400

Clinical trials are fundamental to the development of safe and effective pharmaceutical products, requiring strict adherence to regulatory, ethical, and legal standards. Regulatory affairs play a pivotal role in ensuring that clinical trial activities comply with national and international guidelines designed to protect human subjects and maintain data integrity. This review provides a comprehensive overview of the ethical principles, legal frameworks, and compliance requirements governing clinical trials. Key ethical considerations such as informed consent, protection of vulnerable populations, and the role of ethics committees are discussed in detail. The legal landscape encompassing global regulatory bodies including the US Food and Drug Administration (FDA), European Medicines Agency (EMA), International Council for Harmonisation (ICH), and the Indian Central Drugs Standard Control Organization (CDSCO) is critically reviewed. Furthermore, the importance of Good Clinical Practice (GCP), quality management systems, and regulatory inspections in ensuring trial compliance is highlighted. Recent regulatory updates, challenges in implementation, and emerging trends such as risk-based monitoring and decentralized clinical trials are also examined. This review aims to provide regulatory professionals and postgraduate students with a structured understanding of clinical trial regulations and evolving compliance expectations.

Conclusion: Clinical trials require strict adherence to ethical principles, legal regulations, and Good Clinical Practice to ensure participant safety and data integrity. Strong regulatory oversight and continuous adaptation to emerging trends such as risk-based monitoring and decentralized trials are essential for maintaining compliance and public trust in clinical research.

Pharmaceutical Regulatory Intelligence: Tools, Strategies, and Impact on Product Lifecycle Management

Sonam Shamrao Nimbalkar, Sudarshan Nagrale — Sun, 15 Mar 2026 00:00:00 -0400

Regulatory Intelligence (RI) has become a critical strategic function in the pharmaceutical industry, enabling organizations to navigate complex and evolving global regulatory landscapes. By systematically collecting, analyzing, and disseminating regulatory information, RI supports proactive decision-making across the product lifecycle from early drug development to regulatory submissions and post-approval management. This review examines the tools, strategies, and impact of RI on Product Lifecycle Management (PLM). Traditional tools, such as regulatory authority databases, scientific literature, and internal knowledge repositories, provide foundational support, while digital and automated platforms including artificial intelligence (AI), machine learning, natural language processing, and Regulatory Information Management Systems (RIMS) enhance efficiency, predictive insights, and cross-functional collaboration. Effective RI strategies involve lifecycle-aligned planning, integration with clinical, quality, and commercial teams, performance monitoring, and proactive regulatory engagement. Case studies indicate that organizations with mature RI frameworks achieve faster approvals, optimized lifecycle management, and reduced compliance risks. Challenges include data overload, global regulatory variability, limitations of digital tools, and the absence of standardized performance metrics. Emerging trends, such as AI-enabled analytics, real-world evidence integration, blockchain, and advanced visualization, are expected to further strengthen RI’s strategic role. In conclusion, regulatory intelligence is a transformative tool that improves regulatory preparedness, supports strategic decision-making, and enhances the efficiency and sustainability of pharmaceutical product lifecycles.

Conclusion: Regulatory Intelligence (RI) plays a vital role in strengthening pharmaceutical Product Lifecycle Management by enabling proactive regulatory planning, improving compliance, and accelerating approvals. As digital technologies advance, RI will continue to enhance strategic decision-making and support sustainable innovation.

Reinventing Drug Development and Regulatory Affairs through Artificial Intelligence

Almas Nafis Shaikh, Shoaib Ali Syed — Sun, 15 Mar 2026 00:00:00 -0400

Drug discovery, development, and regulatory approval are traditionally lengthy, costly, and high-risk processes within the pharmaceutical industry. The integration of Artificial Intelligence (AI) offers a transformative approach to overcoming these challenges by enabling data-driven, efficient, and predictive decision-making across the drug development lifecycle. This thesis explores the role of AI technologies, including machine learning, deep learning, and natural language processing, in revolutionizing early drug discovery, preclinical and clinical development, and regulatory affairs. AI-driven methods enhance target identification, lead optimization, clinical trial design, and safety monitoring while reducing development timelines and costs. Furthermore, the study examines the growing application of AI in regulatory processes such as automated dossier review, risk assessment, and pharmacovigilance. Overall, this work highlights AI as a key enabler in modernizing pharmaceutical innovation and regulatory frameworks, ultimately improving the delivery of safe and effective therapies to patients.

Conclusion: The rapid advancement of Artificial Intelligence is fundamentally transforming drug development and regulatory affairs by addressing long-standing challenges related to time, cost, and high failure rates. AI-driven approaches enable more accurate target identification, efficient lead optimization, improved preclinical predictions, and smarter clinical trial design, ultimately enhancing decision-making across the pharmaceutical value chain. In parallel, the adoption of AI in regulatory affairs is modernizing submission processes, risk assessment, and post-marketing surveillance, leading to improved compliance, transparency, and patient safety.

Regulatory Requirements for Participation in WHO Prequalification Programme for Parenteral Products

Aditi Muskan Jha, Maitrey Zaveri, Shirish Patel, Zuki Patel — Tue, 17 Mar 2026 00:00:00 -0400

The Parenteral Product like IV injections, vaccines, etc which is very sensitive including their manufacturing process, storage all plays very important role. A small mistake can destroy the pharmaceutical product and also dangerous for the human kind. Also, in a COVID-Era, we know the importance of the parental product and their life cycle management.

So, this article focuses on the World Health Origination Pre-Qualification Programme which plays very important role in the parenteral product Safety, Quality And their efficacy.

The article contains WHO Prequalification Programme Framework in which all the parameters and its evaluation frameworks. The WHO PQ various stages and their market impact that it can help industry and they can show that their product have the Quality that’s why they have WHO PQ Acceptance Letter. The article review that what is GMP requirements that WHO PQ wants. They also included the how to risk Management and quality Control is necessary. It is also very importance of Stability studies and requirements, for parenteral product this step is very necessary, as stability of parenteral product is very important. The WHO PQ also requires CTD or eCTD dossier which includes various Modules.

Conclusion: The WHO Prequalification Programme plays a crucial role in guaranteeing that injectable products meet global standards for quality, safety, and efficacy by conducting thorough GMP inspections and evaluating CTD dossiers, particularly Module 3 (Quality). For those working in Regulatory Affairs, obtaining WHO PQ approval enhances the product's credibility and facilitates participation in international tenders.

Bridging Regulatory Speed: A US–EU Perspective on Rapid Drug Approvals

Nidhi Anilsingh Bhadauria, Maitreyi Zaveri, Shirish Patel, Zuki Patel — Tue, 17 Mar 2026 00:00:00 -0400

However, there is growing pressure on the regulatory community to provide life-saving drugs to patients sooner, and as such, they have come up with flexible approval processes that attempt to strike a balance between speed and sound evidence. This poster will highlight the key options available in the US and Europe. The FDA's Emergency Use Authorization allows promising drugs to be used on a temporary basis during public health crises before full data is available, while Accelerated Approval allows earlier approval for drugs based on surrogate markers that are reasonably likely to predict clinical benefit. The EMA's Conditional Marketing Authorization allows drugs to be marketed while full data is not available (with a commitment to complete studies later), while Accelerated Assessment is simply an expedited review process for drugs that address serious medical needs. These processes highlight the key differences in the degree of risk that each regulatory authority is willing to take, the amount of evidence required, and the post-approval obligations.

Conclusion: EU and US expedited approval pathways enable faster patient access to critical therapies but require strong post-approval evidence, regulatory harmonization, real-world data integration, and sustained scientific transparency to maintain safety and public trust.