Applied Drug Research, Clinical Trials and Regulatory Affairs - Volume 10, Issue 1, 2024

In response to the surging global demand for medicinal products, the herbal industry faces significant challenges in ensuring the quality of herbal formulations. Regulatory bodies, actively set wanted acceptance limits to different parameters and tries to uphold quality standards. However, the complexities of herbal manufacturing, characterized by batch-to-batch variations and heavy metal residues, pose formidable obstacles. This article also focuses on Ocimum sanctum as a model plant, revealing its cultural, medicinal, ecological, and economic significance in brief. The primary objective of this work is to consolidate diverse quality standards prescribed by different regulatory agencies and to create an empowering resource for farmers to adhere to regulatory parameters for cultivating quality produce. The research employs detailed evaluations, covering macroscopic, microscopic, physicochemical, and toxicity assessments to address the challenges encountered by stakeholders in herbal sector. The study emphasizes the in depth research of verify regulatory standards set by entities such as the Indian Pharmacopoeia, Ayurvedic Indian Pharmacopoeia, Food Safety and Standards Authority of India and World Health Organization to ensure the quality and safety of medicinal products. It underscores the difficulties in maintaining consistent quality with herbal products, including batch variations and exceeding permissible limits of contaminants etc. Despite regulatory efforts, the scattered nature of data necessitates assimilation for effective quality control. Focused on the model plant Ocimum sanctum, the research highlights the imperatives for farmers to adhere to regulatory parameters from inception of cultivation. Additionally, it seeks to consolidate information aiming to bridge the knowledge gap and empower farmers for quality cultivation. In conclusion, the research emphasizes collaborative efforts among regulatory bodies, scientific research, and the agricultural sector to sustain consistent quality standards in the herbal industry and present a comprehensive compilation of quality standards of Ocimum sanctum as a model herb for further commercial exploration in simplified manner.

This comprehensive review delves into the intricate landscape of biosimilars, offering a nuanced exploration of their background, pivotal role in emerging markets like BRICS, and the multifaceted considerations spanning regulatory, quality, manufacturing, pricing, reimbursement, intellectual property, pharmacovigilance, and future trends. The backdrop on biosimilars unravels their significance as a transformative force in healthcare, providing cost-effective alternatives to biologics. The focus then shifts to the emerging markets encapsulated by BRICS, where economic and healthcare landscapes are pivotal determinants in shaping the biosimilar ecosystem. Navigating the regulatory landscape becomes imperative for biosimilar developers, and an overview of regulatory agencies within BRICS underscores the need for harmonized guidelines. Delving deeper, the paper outlines the intricate registration requirements, providing insights into key considerations pivotal for successful biosimilar submissions. Quality, manufacturing, and marketing of biosimilars form a critical triad. Quality attributes and similarity assessments, coupled with analytical methods and characterization, emerge as focal points ensuring the safety and efficacy of these biologic counterparts. Pricing, reimbursement, and market access, the linchpin for successful biosimilar integration, are dissected comprehensively. Pricing policies and strategies, reimbursement considerations, and the plethora of challenges and opportunities associated with market access are examined, offering a holistic understanding of the economic dynamics at play. The intellectual property landscape, delineated through patent regulations, data exclusivity, challenges, and litigation, adds a layer of complexity to biosimilar development and market entry. Pharmacovigilance and post-marketing surveillance emerge as crucial pillars ensuring the ongoing safety of biosimilars. Safety monitoring, risk management plans, and post-marketing surveillance requirements are essential components in this ever-evolving field. The exploration culminates in case studies and market insights, providing tangible examples of successful biosimilar submissions and approvals within the BRICS nations. This segment unveils the current market dynamics, competitive landscapes, and the intricacies of navigating these diverse markets. Looking forward, the paper outlines potential growth prospects and anticipates future trends and opportunities in the biosimilar landscape. It concludes by addressing the evolving policy and regulatory developments, offering stakeholders a comprehensive guide for navigating the dynamic and promising future of biosimilars within the BRICS nations. This work serves as a vital resource for industry professionals, policymakers, and researchers involved in the intricate journey of biosimilar development and market access.

This article presents a comprehensive and comparative analysis of the regulatory frameworks governing the approval of pharmaceuticals in the Dominican Republic, Ecuador, and Nicaragua. It delves into the intricate scientific terminology and complex procedures inherent in these regulatory systems, shedding light on the demanding requirements that pharmaceutical companies must fulfil to secure market access in these countries. Employing a comparative approach, the article explores both the analogy and differences in the approval processes, focusing on factors such as safety standards, efficacy assessments, clinical trial prerequisites, post-marketing surveillance, and overall transparency. The findings contribute to a deeper understanding of the scientific accuracy and ongoing efforts towards regulatory harmonisation within the pharmaceutical industry across these countries. Furthermore, this study aims to define the regulatory requirements for drug approval in the LATAM region, explicitly emphasising the Dominican Republic, Ecuador, and Nicaragua. It provides insights into the current pharmaceutical market landscape in Latin America, compares the regulatory requirements for drug approval in these three countries, and offers guidance on preparing dossiers for obtaining authorisation of pharmaceutical drug products. By examining the similarities and differences in regulatory standards, this article facilitates a comprehensive understanding of the stringency ratios between these countries and assists companies in navigating the specific regulatory landscapes to achieve successful drug approvals.

Treatment of complicated fatal diseases was difficult when nanotechnology was not more popular. The incorporation of nanomedicine has increased in the last 13 years, even though regulatory guidelines regarding nanomaterials and nanomedicine weren't sufficient. Hence, it was tough to decide valid inevitability for the manufacturers, administrators, health professionals, primary care providers, and rest of the public that could ultimately have a negative impact on the financing system, research, and development of such items, affecting the approval of the public and acceptance of nano-products. This review includes coverage across the therapeutic value of nanomaterials, problems in the regulation, regulatory challenges, synthesis, physicochemical properties, and clinical application. The hurdles to using nanotechnology, particularly in the pharmaceutical development of novel medicinal products and respective regulatory issues, are critically explored, considering the characteristics offered by the nanomaterials.

Cell and gene therapy, offering unprecedented solutions for complex diseases, have attracted significant attention in both the scientific and financial communities. This article 
explores the tumultuous financial journey of companies specializing in these advanced therapeutic modalities. The discussion illuminates the volatility of share prices, challenges in 
valuation, and complexities in fundraising while delving into the inherent risks of the cell and gene therapy development pathway. Through an examination of various strategies, the article underscores the importance of diverse investment sources, robust collaborations, risk-sharing models, and portfolio diversification in ensuring financial stability. As the field burgeons, understanding these financial dynamics is paramount for stakeholders aiming to harness the transformative potential of cell and gene therapies.

Many non-biological drugs, different in terms of their structure and mode of action, pharmacological classification, and therapeutic indication, have a common factor of structural complexity and are grouped as non-biological complex drugs (NBCDs). When an innovator drug nears the time of off-patent, different manufacturers attempt to produce its subsequent version, so the patients will have a cost-effective therapeutic equivalent. Since the innovator molecule is complex, its follow-on drug can be called its true generic version, if its bioavailability, bioequivalence and therapeutic equivalence to the innovator drug are demonstrated. However, it is observed that a case-to-case basis approach is implemented by European Medicines Agency (EMA) and Food and Drug Administration, US (USFDA) in the approval of such drugs and there is no uniformity observed between the two.

In this study, an attempt is made to study the complexity of molecules compare and understand the data requirements, and procedures adopted for the review and approval of such complex products. Therefore, drug sevelamer carbonate and glatiramer acetate are selected for the study. A methodical approach was followed. European assessment reports and drug approvals available in the orange book database of the former two regulatory agencies were studied. It is observed that the generic version of glatiramer acetate is approved as an abbreviated new drug application (ANDA) by Food and Drug Administration whereas the same was approved as the hybrid application by European Medicines Agency requiring the applicant to generate and submit more data. Thus, harmonization of the regulatory requirements for the approval of follow-on versions of such complex drugs is essential for better understanding, predictability of the regulatory process, and acceleration of the drug approval process, in the interest of patients. This will help the faster access of the drugs to the patients and allow interchangeability of the innovator drugs with its cost-effective generic version.