International Journal of Drug Regulatory Affairs

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

2025-12-21T12:50:26-05:00

Background: Increasing evidence from basic and clinical studies indicates that oxidative stress plays a critical role in the pathogenesis of age-related macular degeneration (AMD). Therefore, natural agents with antioxidant properties may serve as promising therapeutic candidates. This study investigated the protective effects of almond milk against hydrogen peroxide (H₂O₂)-induced oxidative damage in retinal pigment epithelial (ARPE-19) cells and evaluated its biological activities.

Material & methods: Cytotoxicity of shelled and unshelled almond milk was assessed using the MTT assay. Antimicrobial activity was investigated via the disc diffusion method. Total antioxidant capacity and free radical–scavenging activities were determined spectrophotometrically. The proliferative effects of almond milk on Lactobacillus rhamnosus GAA6 and Lactobacillus reuteri ENA31 were evaluated in MRS medium.

Results: H₂O₂ reduced ARPE-19 cell viability in a concentration-dependent manner (25–500 μM), and the concentration causing approximately 50% cytotoxicity was determined as 50 μM. Almond milk significantly enhanced cell viability in ARPE-19 cells treated with H₂O₂, demonstrating a concentration-dependent protective effect. Total antioxidant capacity was measured as 3.52 mmol/L for shelled and 2.04 mmol/L for unshelled almond milk. Neither form exhibited antimicrobial activity against tested pathogens. Both almond milk types promoted the proliferation of probiotic Lactobacillus strains.

Conclusion: Almond milk provides notable protection against H₂O₂-induced oxidative damage in ARPE-19 cells and demonstrates prebiotic activity. Owing to its natural origin and biological properties, almond milk has potential as a therapeutic supplement and a functional protective food.

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

2025-12-21T11:37:04-05:00

Accelerated approval pathways for generic medicines improve patient access and reduce healthcare costs by speeding market entry without compromising quality. The U.S., Switzerland, the U.K., and Japan have developed distinct mechanisms to prioritize generic application reviews amid evolving regulatory frameworks. This review compares fast-track approval criteria, review timelines, documentation requirements, and reliance or harmonization efforts across the FDA, Swissmedic, MHRA, and PMDA. A systematic literature search from January 2000 to June 2025 included peer-reviewed articles and official guidance. Data on review timelines, eligibility criteria, dossier requirements, and reliance agreements were extracted using a standardized template. Comparative tabulation identified similarities and differences. The FDA’s Priority Review targets an eight-month approval for eligible ANDAs, supported by GDUFA performance goals. Swissmedic’s accelerated assessment shortens review from 330 to 150 days, enabled by pre-application hearings and the Access Consortium. MHRA offers 60- and 110-day tracks through the International Recognition Procedure by accepting reference regulators’ decisions. PMDA prioritizes generics within a nine-month timeline, supplemented by pre-submission consultations and "Harmonization by Doing" initiatives. All agencies require bioequivalence via ICH CTD modules but differ in clock-stop policies, administrative demands, and reliance frameworks.

Conclusion: While agencies align on bioequivalence and dossier formats, differences in timelines, review mechanisms, and dossier requirements challenge submission planning. Standardizing performance goals, reducing administrative burdens, and harmonizing reliance agreements are emerging good practices supporting faster global access to generic drugs.

Comparison and Registration Pathway of Nutraceuticals in Canada, India, Australia, Japan and South Korea

2025-12-21T11:47:12-05:00

One of the areas of healthcare that is expanding the fastest is nutraceuticals, which are dietary products that offer health advantages beyond simple nourishment. Nonetheless, there is still fragmentation in the global regulation of these items, with many nations implementing unique frameworks for post-market surveillance, approval and classification. This article compares the regulatory pathways for nutraceuticals in Canada, India, Australia, Japan and South Korea, highlighting similarities, differences and unique country-specific requirements. The review identifies that while Canada and South Korea emphasize pre-market approval systems, Australia and Japan employ tiered approaches, allowing both lighter oversight (notification-based) and stricter evaluations (clinical trial-based). India, meanwhile, classifies nutraceuticals primarily under food law, with emphasis on safety and compliance. The findings reveal a lack of global harmonization, leading to challenges in international trade, product registration and consumer protection. Recommendations include strengthening scientific validation, fostering regulatory convergence and enhancing post-market surveillance.

Data Integrity in Pharmaceuticals

2025-12-21T11:51:44-05:00

In the pharmaceutical world, maintaining data integrity represents one of the most critical aspects of ensuring that medications reach patients safely and effectively. This concept goes far beyond simple record keeping it encompasses the entire journey of information from initial research through final product delivery, ensuring that every piece of data remains accurate, reliable, complete, and consistent throughout this process. The regulatory landscape has evolved significantly, with organizations like the FDA establishing comprehensive guidelines such as 21 CFR Part 11, alongside internationally recognized frameworks like ALCOA+ and ICH Q7. These standards emphasize that pharmaceutical data must be attributable, legible, contemporaneous, original, and accurate, while also being complete, consistent, enduring, and available whenever needed. The importance of data integrity extends well beyond regulatory compliance. When pharmaceutical companies maintain robust data practices, they build trust with patients, protect public health, and foster transparency across all operational levels. However, the path to achieving this ideal is fraught with challenges, including human errors, inadequate digital infrastructure, poor documentation practices, and increasingly sophisticated cybersecurity threats. To address these challenges, companies are implementing comprehensive risk-based approaches, investing in advanced digital technologies, and cultivating organizational cultures that prioritize quality and accountability. This paper explores the fundamental principles governing data integrity, examines regulatory requirements, identifies common pitfalls, and presents best practices for maintaining data integrity in pharmaceutical operations.

Post-Market Surveillance Evolution: Pharmacovigilance 2.0 and the future of global Drug Safety

2025-12-21T12:18:03-05:00

Pharmacovigilance (PV) plays a critical role in ensuring the safety of drugs and vaccines after marketing authorization. Traditionally, PV systems relied heavily on spontaneous adverse drug reaction (ADR) reporting, which often faced challenges such as underreporting, fragmented data sources, and delays in signal detection. The COVID-19 pandemic highlighted these shortcomings, creating an urgent need for more efficient, technology-driven systems. This led to the emergence of “Pharmacovigilance 2.0,” characterized by the integration of artificial intelligence (AI), real-world evidence (RWE), big data analytics, and digital platforms, including mobile applications, for active and predictive safety surveillance. In India, the Pharmacovigilance Programme of India (PvPI) has strengthened ADR reporting networks, signal detection capabilities, and risk communication mechanisms. Meanwhile, in the United States, the FDA’s Sentinel 2.0 system utilizes advanced analytics to proactively monitor post-market drug safety in near real time. This article explores the evolution of PV systems in both countries, comparing key innovations, highlighting regulatory advancements, identifying existing challenges, and proposing future directions for achieving harmonized, globally efficient drug and vaccine safety frameworks.

A Strategic Analysis of Work-Sharing: Access Consortium, Project Orbis, and Project Optimus

2025-12-21T12:24:58-05:00

A more cooperative paradigm is replacing the days of strictly sequential, nation-by-nation drug approvals. Navigating the terrain of international cooperation is now a core competency for the modern regulatory professional rather than a specialized skill. This article goes into detail about three collaborative models that could change the way regulatory affairs professionals work: the Access Consortium, Project Orbis, and Project Optimus. It breaks down the different ways that Access and Orbis share work, which are changing the timelines for submissions, and compares them to Project Optimus, a scientific project that is fundamentally changing the DNA of oncology development. This paper goes beyond merely describing the programs to examine how they operate, what strategic trade-offs they entail, and where they might be able to exert greater influence. The goal is to provide organizations with the information they need to navigate this new, collaborative world and transform regulatory complexity into a competitive edge.

Artificial Intelligence in Pharmaceutical Regulatory Affairs and Medical Science Liaison Activities: A Comprehensive Review

2025-12-21T12:45:57-05:00

Artificial Intelligence (AI) is transforming pharmaceutical regulatory affairs and Medical Science Liaison (MSL) activities by improving efficiency, accuracy, and decision-making. In regulatory affairs, AI enables automation in dossier preparation, regulatory intelligence, and pharmacovigilance, significantly reducing human error and turnaround times. For MSLs, AI facilitates analysis of large datasets, identification of Key Opinion Leaders (KOLs), and personalized communication with healthcare professionals. Despite these advancements, challenges such as data privacy, algorithmic transparency, and bias in AI algorithms persist. This review synthesizes recent studies and provides insights into the applications, benefits, challenges, and future directions of AI in these critical domains of pharmaceutical operations.

Clinical Research Regulation in India and Brazil: An Overview of Current Frameworks and Implementation Gaps

2025-12-21T12:56:04-05:00

Clinical research in emerging economies has expanded significantly over the past two decades, necessitating robust, transparent, and ethical regulatory systems. India and Brazil two major middle-income countries with rapidly growing clinical trial sectors have implemented substantial reforms aimed at strengthening participant protection, streamlining approval pathways, and improving regulatory oversight. This review provides a comparative examination of the current clinical trial regulatory frameworks in India and Brazil, highlighting their legal foundations, governance structures, ethical oversight mechanisms, and operational requirements. In India, the New Drugs and Clinical Trials Rules (NDCTR) 2019 established a consolidated, clearer, and more time-bound regulatory pathway, with mandatory ethics committee registration and enhanced safety reporting obligations. Brazil, through ANVISA regulations and the National Research Ethics Commission (CONEP), has progressively harmonized ethical and scientific review processes, with noteworthy reforms introduced by Law No. 14,874/2024 and updated ANVISA Resolutions. Despite these advances, both countries continue to face implementation gaps, including delays in multicenter trial approvals, variations in ethics committee capacity, limited inspection resources, and challenges in transparency and post-trial access. Comparative analysis reveals opportunities for regulatory convergence, digitalization of review processes, and strengthened collaboration between national authorities to support global clinical research. Addressing these systemic gaps will be essential for building public trust, enhancing research quality, and positioning India and Brazil as reliable hubs for ethical and scientifically sound clinical trials.

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

2025-12-21T13:00:34-05:00

Artwork design involves creating and developing visual components, layouts, and graphic illustrations used in the packaging and labeling of medicinal products. These designs represent a paramount role in linking essential information about medications and ensuring adherence to regulatory compliance. Despite their significance, pharmaceutical industries confront several hindrances in artwork design, such as meeting regulatory requirements, maintaining brand consistency, addressing multilingual needs, and managing time and cost constraints.

This article discusses the process of managing packaging artwork design within the pharmaceutical industry and outlines the EU regulatory requirements aimed at standardizing artwork compliance. It elucidates the assessment process according to the Directives and Regulations for mock-ups and specimens of immediate (primary) and outer (secondary) labeling, as well as package leaflets for medicinal products in the centralized procedure.

The article also outlines a comparison of labeling workflows and submission processes across the EU, US, Australia, and Japan. Furthermore, it highlights the influence of packaging artwork on brand recognition and marketing approach, emphasizing patient safety through precise pharmaceutical packaging information. Additionally, it expounds the significance of artwork review and change control management. It also shows the proportion of recalls in the US and the EU over the past years. It outlines strategic perspectives and the latest updates that are influencing EU labeling practices in 2025.

Evolution of Clinical Trial Regulations in Cote D’Ivoire

2025-12-21T12:57:58-05:00

Clinical trials are an essential step in bringing innovative medicines to market. Their effective regulation, which protects participants in these trials, is important in West African’s heavy dependence on foreign sources for medicines context, and particularly in Côte d'Ivoire where the government has expressed its desire to develop the local pharmaceutical industry, including innovation. The objective of this study was to describe the regulations governing clinical trials in Côte d’Ivoire. The methodology used consisted in identifying and then analyzing the applicable texts to clinical trials as well as the reports emanating from the bodies involved in the regulation of clinical trials. The results of our study reveal that in Côte d'Ivoire, since 1987, clinical regulation trials, characterized by the creation and organization of the main bodies in charge of managing these trials, has not really evolved. It took about thirty years to observe a major evolution in regulations with the adoption of Presidential Decree No. 2020-407 of April 22, 2020 regulating clinical trials in Côte d’Ivoire. This salutary text incorporates general principles universally accepted in this area such as the protection of persons and their free and informed consent before any testing is conducted. This confirms the role of the Ivorian Pharmaceutical Regulatory Authority in clinical trials monitoring, while still considering National Ethics Committee mandatory opinion. This development in Ivorian regulations is part of a sub-regional project to regulate clinical trials and will become effective with implementing regulations adoption.

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

2025-12-21T12:38:41-05:00

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) introduced stringent requirements for clinical evidence, device reclassifications, and more robust post-market surveillance measures, creating significant challenges for the medical technology industry. The compliance of a portfolio exceeding 2,500 products within Dräger's Hospital Consumables and Accessories (HCA) Business Unit was managed, with MDR certification achieved prior to the regulatory deadline of May 26, 2024.

The study examines a methodological shift in Regulatory Affairs (RA) from a post-development review function to a proactive consultancy role. By optimizing processes, driving cultural change, and embedding RA expertise early in the R&D V-Model alongside Product Management (PM), this methodology streamlined development timelines, reduced costs, and prioritized resources for critical markets. The result was enhanced operational efficiency and adaptability on a global scale.