International Journal of Drug Regulatory Affairs

Functional Food Interventions for Mitigating Cardiovascular Risk Markers in Adults

Mos Najma Akter — Tue, 16 Sep 2025 14:05:04 -0400

The purpose of this cross-sectional study was to determine the extent to which taking functional food affects the cardiovascular risk parameters of adults. A standardized questionnaire was applied to collect diet habits, knowledge and frequency of functional food intake as well as self-reported cardiovascular indicators comprised of blood pressure, cholesterol, triglycerides, and glucose from 512 individuals aged 25 to 65 years. Most participants (78%) knew about functional foods and oats, nuts, and fatty fish were the products most ingested. Higher consumption of β-glucan-rich foods (≥ 5 times/week) was significantly related to lower odds ratio for high cholesterol (OR: 0.66, p = 0.03), and that of omega-3 rich foods was significantly associated with reduced odds ratio for hypertriglyceridemia (OR: 0.60, p = 0.02). There was no significant relation with plant sterol fortified food intake and LDL cholesterol, largely because usage was low. Obstacles to utilization were cost and lack of availability. The results indicated that the increased consumption of some functional foods was accompanied by a more favorable cardiovascular risk profile. The results also highlighted the significance of recommending functional foods in preventive policies.

Remarkable facts when concluding contracts for the conduct of clinical trials for medical devices in Germany

Raees Ahmed — Wed, 17 Sep 2025 14:17:38 -0400

Introduction: The objective of clinical trials for medical devices is primarily the investigation and evaluation of their performance and safety. Of particular importance in this context is the contractual design of clinical trials for medical devices in the relationship between the sponsor and the trial center. The legal basis for this is the German Medical Device Implementation Act (Medizinprodukterecht-Durchführungsgesetz (MPDG)), which came into force on May 26, 2020, and is intended to concretize the EU regulations on medical device law at national level. Due to the principal of private autonomy, there are various options to draw contracts for the implementation of clinical trials for medical devices. However, certain points should be considered when drafting the contract and should become part of the contract. These include a heading and a preamble - they serve to clarify the contract and introduce its contents. Other important parts of the contract are the subject matter, contractual obligations, subject recruitment, audit and inspection, monitoring, provisions for premature test termination, test components, remuneration, contract duration and termination options, confidentiality, partial invalidity, and applicable law. They define the complex legal relationship between the clinic, the investigator and the sponsor, as parties to the contract.
Materials & methods: A specific data base was used for law www.beck-online.de and digital journal archives (https://ezb.ur.de;www.digizeitschriften.de) at Universitätsmedizin Göttingen. All assumptions are based on the authors own day-to-day experience as a lawyer or legal advisor at legal department of Universitätsmedizin Göttingen.
Discussion & Conclusion: For the legal certainty of all parties, the contractual components should definitely become part of the content of contracts for the performance of clinical trials for medical devices. It should be noted, however, that individual cases and their contractual requirements should be considered.

Understanding Clinical Investigation and preparation of Technical file for Continuous Positive Airway Pressure (CPAP) Medical Device

Vedant L. Dixit, Sahil S. Gupta, Milind J. Umekar , Vinita V. Kale — Mon, 15 Sep 2025 11:06:59 -0400

Continuous Positive Airway Pressure (CPAP) devices are essential medical tools for managing Obstructive Sleep Apnoea (OSA) it is a disorder marked by frequent blockages of the upper airway while a person is asleep. This review delves into the clinical investigation, design considerations, regulatory standards, and technical documentation involved in CPAP development. CPAP devices deliver continuous airflow through a mask to prevent airway collapse, thereby restoring normal respiration during sleep. Due to their moderate risk classification across various regulatory bodies (e.g., FDA Class II, CDSCO Class B/C, EMA Class IIa/IIb), manufacturers must adhere to stringent global standards, including ISO 13485 (Quality Management System), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), and IEC 60601 (Electrical Safety), and IEC 62366 (Application of Usability Engineering) This review elaborates on the structure and importance of the Device History File (DHF) and the Technical File, which document all phases from design inputs and outputs to risk analysis, usability, validation, and post-market surveillance. Detailed insights are provided into biocompatibility assessments, environmental testing, and clinical evaluations comparing CPAP with Mandibular Advancement Splints (MAS). The study highlights CPAP’s superiority in reducing the Apnoea-Hypopnea Index (AHI) and improving physical health scores, although MAS demonstrated better adherence and comfort. A critical case study of Philips’ 2021 recall further emphasizes the importance of material biocompatibility and robust risk management. This review ultimately serves as a comprehensive resource for developers aiming to ensure regulatory compliance and patient safety in CPAP manufacturing.

A study on the US FDA Regulatory requirements for Stem Cell Based-Products

Abdul Mannan, Zuha Fatima, Mohammed Yamin Salman — Mon, 15 Sep 2025 00:00:00 -0400

Purpose: To thoroughly investigate the regulatory structure implemented by the U.S. Food and Drug Administration (FDA) for products derived from stem cells. As regenerative medicine advances, it is essential to comprehend the FDA's function in safeguarding the safety, effectiveness, and quality of these therapies.

This research utilizes a thorough method to explore the regulatory requirements set by the U.S. Food and Drug Administration (FDA) for stem cell-derived products. The approach combines qualitative analysis, document review, and case study assessment to evaluate the FDA's regulatory structure and its influence on the advancement and authorization of regenerative treatments.

Results and discussion: This research examine the U.S. FDA's regulatory framework for stem cell-derived products, including combination products. It clarifies the distinctions between Section 361 and Section 351 HCT/Ps based on criteria like minimal manipulation and homologous use. The article discusses various regulatory pathways, emphasizing the need for Investigational New Drug (IND) and Biologics License Applications (BLA). Additionally, it explores the regulation of stem cell combination products, which may involve devices or drugs. The FDA's strategy for regulating stem cell-based products demonstrates a dedication to finding a balance between innovation and patient protection. Although important advancements have been achieved in creating explicit guidelines and enforcement strategies, persistent challenges in product characterization, manufacturing processes, and international cooperation need ongoing focus.

Navigating the Regulatory Maze: Compliance Strategies for GHK-Cu in the Global Cosmetic Industry

Luckyrajsinh Vaghela, Nrupesh Patel — Mon, 15 Sep 2025 00:00:00 -0400

Introduction: This study aims to explore the complex regulatory frameworks governing the use of GHK-Cu (Copper-binding tripeptide complex) in cosmetic formulations across various global markets. It evaluates the challenges manufacturers face in ensuring compliance while maintaining product efficacy and safety.

Scope: The analysis draws from international cosmetic regulations, scientific literature on GHK-Cu, and case studies across the EU, USA, Asia-Pacific, and other markets. Official publications by regulatory bodies and peer-reviewed journals were also referenced.

Objective: The article reviews scientific studies validating GHK-Cu's safety and effectiveness, regulatory guidelines from jurisdictions such as the FDA, EU Commission, CDSCO (India), and MFDS (South Korea), and industry reports concerning compliance and market entry.

Summary of Contents: GHK-Cu, a naturally occurring peptide with anti-aging and regenerative properties, is widely incorporated in skin care. However, its regulatory status varies significantly worldwide. While the EU demands extensive pre-market safety assessments, the USA adopts a more lenient but scrutinized post-market model. Asian countries exhibit diverse approaches. The article discusses labeling, marketing claims, clinical validation, and the economic burden of compliance. It also presents strategic solutions, including early regulatory engagement, transparent labeling, sustainable sourcing, and emerging testing technologies.

Conclusion: Navigating international compliance for GHK-Cu-based products requires a multifaceted, proactive approach that integrates scientific validation, regulatory intelligence, and market-specific strategies. Harmonization efforts and stakeholder collaboration are essential to foster innovation and ensure consumer safety.

The Integration of Wearable Devices with mHealth Apps for Remote Patient Monitoring: A Literature Review

A.S.M Anas Ferdous, SK Shamiur Rahman — Mon, 15 Sep 2025 13:53:59 -0400

Wearable devices and mobile health (mHealth) applications have transformed healthcare by facilitating real-time remote patient monitoring (RPM). These technologies provide ongoing monitoring of vital signs, management of chronic diseases, and tailored health treatments, enhancing patient outcomes and decreasing hospital readmissions. The amalgamation of artificial intelligence (AI) and the Internet of Things (IoT) has augmented the efficacy of remote patient monitoring (RPM) through predictive analytics, automatic notifications, and fluid data interchange. This literature study seeks to examine the amalgamation of wearable devices with mHealth applications, emphasizing their development, advantages, obstacles, and prospective future. The review consolidates recent studies on wearable-integrated healthcare solutions, highlighting their uses in chronic illness management, post-surgical monitoring, geriatric care, and mental health assessment. Essential findings demonstrate that wearable-integrated mHealth applications augment patient engagement, enable early disease identification, and refine clinical decision-making. Nonetheless, considerable hurdles remain, encompassing data privacy issues, limitations in sensor accuracy, interoperability complications with Electronic Health Records (EHRs), and sustained user adherence over time. Identified research needs encompass the necessity for advanced AI-driven health forecasts, fortified data security protocols, and standardized frameworks for the smooth integration of healthcare systems. Future research must prioritize the advancement of more dependable and secure wearable health technology, enhance access to digital healthcare for marginalized people, and undertake extensive clinical trials to substantiate wearable-based remote patient monitoring systems. By tackling these problems, wearable-integrated mHealth applications can significantly influence the future of patient-centered, data-driven healthcare.

Validation of Aseptic Process in Sterile Pharmaceutical Facility in accordance with ICH Guideline

Rushikesh Kadu, Amey Umaley, Rupesh Chavhan, Ajay Pise — Tue, 16 Sep 2025 14:17:09 -0400

This review article focuses on the validation procedures and guidelines outlined by the International Council for Harmonization (ICH) for ensuring the efficacy and safety of aseptic processes in sterile pharmaceutical facilities. Aseptic processing is critical in pharmaceutical manufacturing to prevent contamination and ensure product sterility. The ICH guidelines provide a comprehensive framework for the validation of aseptic processes, encompassing facility design, equipment qualification, process validation, and ongoing monitoring. Aseptic validation is a systematic process that ensures sterile products are consistently manufactured under controlled conditions.

It begins with facility and equipment design, focusing on cleanroom layout, air handling systems (HVAC), and controlled environments that minimize contamination risk. Personnel qualification and training are critical to maintaining aseptic practices. The validation process typically includes: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Media Fill / Process Simulation. Various techniques such as environmental monitoring, media fill studies, and microbiological testing are employed to assess the ongoing performance of aseptic processes. Adherence to ICH guidelines not only ensures regulatory compliance but also promotes the production of high-quality, safe, and efficacious sterile pharmaceutical products. This review consolidates key principles and best practices for validating aseptic processes, serving as a valuable resource for pharmaceutical professionals involved in sterile manufacturing and regulatory compliance.

Pharmaceutical 3D Printing: A Promising Technology for creating customized Medications

Swapnil More — Tue, 16 Sep 2025 14:27:41 -0400

Three-dimensional printing (3DP) enables the development of diverse geometries through computer aided design using different techniques and materials for desired applications such as pharmaceutical drug delivery system. Now a days 3D PRINTING technology has caught the attention of medical devices industry and pharmaceutical industry due to its applications on various platform in health care industry. Although this technology has been around for quite some time, it is currently of significant public interest, especially following the approval of 3-D printed tablets and other medical devices. Additionally, the introduction of the USFDA’s guidance on technical aspects related to devices utilizing additive manufacturing, which includes 3-dimensional (3D) printing, has sparked numerous considerations about this technology that are essential for the effective delivery of the intended product. It emerges as one of the most influential and impactful tools utilized for the accurate production of advanced dosage forms, tissue engineering, and disease modeling.

Conclusion: 3D printing is emerging as a transformative technology in the pharmaceutical and medical device industries, enabling precise fabrication of advanced drug delivery systems, tissue engineering solutions, and disease models. With growing regulatory support and proven applications, it holds significant potential to shape the future of personalized healthcare.

The future of Regulatory Submissions: Transition to eCTD 4.0

Komal Nagar, Mamta Choudhary, Bharti Yadav, Shivali Rahi, Ashutosh Upadhayay — Tue, 16 Sep 2025 00:00:00 -0400

As a global standard for regulatory submissions, the electronic Common Technical Document (eCTD) has improved efficiency among health authorities and streamlined procedures for pharmaceutical and biological products. The introduction of eCTD version 4.0 represents a significant digital leap with enhanced lifecycle management, interoperability, and message-based architecture. This transition supports more effective data handling and fosters cross-border regulatory cooperation. eCTD 4.0 offers advantages such as reduced redundancy, real-time communication, and increased submission flexibility by moving away from document-centric models to a modular, data-centric framework. Regulatory agencies including the FDA, EMA, PMDA, and Health Canada are at various implementation stages, signaling global commitment to submission modernization. This review examines the evolution, benefits, challenges, and strategic opportunities associated with the implementation of eCTD 4.0 in global regulatory systems.

Conclusion: The transition to eCTD 4.0 marks a major advancement in regulatory submissions, offering a more flexible, interoperable, and data-driven framework. By addressing the limitations of earlier versions, it enables improved efficiency, communication, and global harmonization.

Modernizing Good Clinical Practice: Key Insights and Impact of ICH E6(R3) Guideline

Akash Aher — Wed, 17 Sep 2025 00:00:00 -0400

An updated version of the Good Clinical Practice Guideline, E6(R3), has been made available by the International Council for Harmonization. This guideline places a strong emphasis on a more adaptable, risk-based method of trial supervision. Quality by Design (QbD) adoption, attention to Critical-to-Quality (CtQ) factors, participant safety enhancement, adoption of Digital Health Technologies (DHTs), decentralized trials, elucidation of sponsor, investigator roles and responsibilities are some of the major effects. The implementation of risk-based monitoring, updating SOPs, quality systems, bolstering data governance with technologies like audit trails and metadata are examples of operational impacts. These updates seek to minimize needless burden, safeguard the rights, safety, and well-being of trial participants, promote innovation in trial design and conduct, and assure data reliability.

Conclusion: This review article provides a comprehensive review of the major revisions to the GCP guidelines, offering insights into the E6(R3) framework, its key impacts, and the essential takeaways for modern clinical trial conduct.

Drug Labelling Regulations in the USA, Europe, and India: An Overview

Wed, 17 Sep 2025 14:03:21 -0400

Labelling on drugs is a vital communication means that facilitates proper use of medicine safely and effectively by communicating core information to prescribing physicians and patients. Objective: This research aims to provide comparative examination of requirements for prescription labelling in three regulatory super jurisdictions: The United States of America, the European Union, and India. Data source: The research comprehensively analyses the regulatory directives for labelling exercises in these regulatory super jurisdictions, which include the guidelines of the U.S. FDA, the European Medicines Agency (EMA), and India's Central Drugs Standard Control Organization (CDSCO).

Conclusion: Regulatory expectations regarding key components such as labelling formats, required content, language, and patient safety and risk communication strategies are found to be majorly similar and divergent. This study identified regulatory gaps, industry challenges, and potential harmonization strategies to facilitate global trade. By understanding these frameworks, stakeholders can navigate compliance more efficiently, fostering growth in labelling practices across the USA, Europe, and India.

The Role of Contract Law in Shaping the Pharmaceutical Sector: A Legal Study

Arun Nanda, Sanju Nanda — Wed, 17 Sep 2025 14:11:47 -0400

Any agreement which can be enforced by law is a contract. The law of contracts is crucial in pharmacy, regulating agreements between various stakeholders like pharmaceutical companies, suppliers, distributors, government entities and even patients. These contracts cover areas like supply agreements for raw materials and finished products, clinical trial agreements, licensing agreements for intellectual property, and more. Effective contract management ensures compliance, minimizes risk, and facilitates the smooth operation of the pharmaceutical industry. Business connections are established by every pharmaceutical company, with different manufacturers, suppliers, service providers, financial institutions, etc. In all these transactions, contracts are involved and regulatory authorities worldwide mandate for clearly defined, agreed and controlled contracted services. Various types of contracts, along with types of clauses required to be covered in such contracts, which are entered into by the pharmaceutical industry, with its various stakeholders, in India as well as outside, have been explored in this article. The application of Law of Contracts has been illustrated in the regulatory agencies of USA, European Union and India. Application of Law of contracts has been explored from the stage of inception to closing of a pharmaceutical company. The three types of contracts (Contracts by Agreement, Standard Form Contract and Promissory Estoppel) have been described, with cited case studies. Salient features, key types of agreements, key considerations, common examples, and specific applications in pharmaceutical industry, common clauses, of the three types of contracts have been described. The authors conclude that in view of the significant application of Law of Contracts in pharmaceutical industry, it would be prudent if the students / researchers in pharmacy, particularly those in the area of drug regulatory affairs, be fully aware of this law, and that this law may be included in the Pharmacy curriculum.