Regulatory Affairs Research Articles

Review on vital role of regulatory affairs in pharmaceutical industry

The burgeoning field of Regulatory Affairs (RA) serves as the foundation for ensuring public health in today's globalized marketplace. In the pharmaceutical industry, regulatory affairs play a crucial role in assuring the safety, efficacy, and quality of drug products, which are essential for the approval of new products entering the market. Emerging from a collective international desire to protect individuals from potentially harmful medications, this profession bridges the gap between pharmaceutical companies and regulatory agencies, ensuring that products meet all necessary legal and scientific standards.Regulatory affairs professionals act as guardians, meticulously ensuring the accuracy and completeness of product information. They navigate the complex labyrinth of regulations, translating them into practical plans for companies to follow. Their expertise encompasses the entire life cycle of a drug, from initial application submission and oversight of clinical trials to ongoing adherence to evolving regulatory requirements. This comprehensive approach guarantees the development, manufacturing, and distribution of safe and effective medications across various fields, including traditional pharmaceuticals, veterinary medicine, medical devices, and complementary therapies.As the pharmaceutical landscape continues to evolve, the demand for highly skilled regulatory affairs professionals remains strong. In India, the Central Drug Standard Control Organization (CDSCO) regulates drug legislation, facilitating drug development from initial research to market approval and post-marketing surveillance.

First evidence of ichnopathologies in Rhinoceripeda tasnadyi tracks from the Miocene of Hungary

Despite a vast record, ichnological evidence of malformed or injured animals is extremely rare. During the re-examination of slabs collected from the Ipolytarnóc tracksite (Early Miocene, North Hungary) and housed at the Supervisory Authority for Regulatory Affairs, three “atypical” tracks were detected along the same trackway. They belong to the ichnotaxon Rhinoceripeda tasnadyi, attributed to a medium- to large-sized “hornless” Miocene rhinocerotids. The hoof of the left digitIII appears to be split, rather than oval, at approximatively half of its width, giving an almost tetradactyl appearance to the footprints. The deformation due to overprinting is excluded because of the number of tracks showing the same variation. This injury/malformation could be identified as the atypical tracks belong to a trackway where the opposite impression is preserved and due to the large number of accessible R. tasnadyi footprints. These account for a wide range of the standard variability of the morphology at Ipolytarnóc. If the track record was limited, or when the abnormal tracks do not belong to a trackway, it would not be possible to recognise those differences as ichnopathologies and, as a result, a different trackmaker would have been assessed, or a wrong ichnotaxonomical diagnosis would have been attributed.

Enhancing regulatory affairs in the market placing of new medical devices: how LLMs like ChatGPT may support and simplify processes

Enhancing regulatory affairs in the market placing of new medical devices: how LLMs like ChatGPT may support and simplify processes

Navigating the Regulatory Maze: The Vital Role of Regulatory Affairs in Pharmaceutical Safety and Quality

The real struggle of pharmaceutical industries for survival lies in performing processes by following the guidelines of various regulatory authorities around the globe to provide assured quality of the process under regulations [1]. A profession under-regulated industry, such as that controlling pharmaceuticals, medical devices, energy, and banking, is called Regulatory Affairs (RA) [2]. They may involve minor or major multinational corporations, including innovative biotechnology companies, which have a specific meaning and a separate specialized depart-ment of RA professionals. This department helps to guide the company on the regional and global laws and regulations set forth by different regulatory authorities and helps safeguard the products’ life cycle. The purpose of regulatory departments or pro-fessionals is to develop and promote heavily controlled therapeutic or pharmaceutical goods and build a platform for marketing approval. In addition to this, RA in the pharmaceutical industry is comparatively a new field to safeguard public well-being by monitoring the safety and efficacy of the products [3]. Furthermore, in the late 1950s, multiple tragedies resulted in an increase in legislation for pharmaceutical goods’ quality, safety, and efficacy. As a part of this, strict norms were made for Marketing Authorization (MA) and Good Manufacturing Practice (GMP) [4]. These tragedies included (i) sulphanilamide elixir; (ii) vac-cine tragedy; and (iii) thalidomide tragedy [4]. The present article covers the regulatory affairs’ responsibilities and importance in the context of pharmaceutical industries.

More than red tape: exploring complexity in medical device regulatory affairs.

This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs. These interviews were analyzed using a mix of qualitative coding and natural language processing (NLP) techniques. The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (1) regulatory language complexity, (2) intricacies within the regulatory process, (3) global-level complexities, (4) database-related considerations, and (5) product-level issues. The participants highlighted the need for strategies to streamline regulatory compliance, enhance interactions between regulatory bodies and industry players, and develop adaptable frameworks for rapid technological advancements. Emphasizing interdisciplinary collaboration and increased transparency, the study concludes that these elements are vital for establishing coherent and effective regulatory procedures in the medical device sector.

Streamlining Change Control Processes in Regulatory Affairs: Best Practices and Case Studies

Change control is a critical component of regulatory affairs in various industries, particularly in pharmaceuticals, medical devices, and biotechnology. This research paper explores the challenges associated with traditional change control processes and presents best practices for streamlining these processes to improve efficiency, compliance, and overall product quality. Through a comprehensive literature review and analysis of case studies from leading organizations, we identify key strategies for optimizing change control workflows, leveraging technology, and fostering a culture of continuous improvement. The paper also examines the impact of streamlined change control processes on regulatory compliance, product lifecycle management, and organizational performance. Our findings suggest that implementing these best practices can lead to significant reductions in change implementation time, improved regulatory compliance, and enhanced product quality and safety.

A roadmap for clinical trials in MASH-related compensated cirrhosis.

Although metabolic dysfunction-associated steatohepatitis (MASH) is rapidly becoming a leading cause of cirrhosis worldwide, therapeutic options are limited and the number of clinical trials in MASH-related compensated cirrhosis is low as compared to those conducted in earlier disease stages. Moreover, designing clinical trials in MASH cirrhosis presents a series of challenges regarding the understanding and conceptualization of the natural history, regulatory considerations, inclusion criteria, recruitment, end points and trial duration, among others. The first international workshop on the state of the art and future direction of clinical trials in MASH-related compensated cirrhosis was held in April 2023 at Vall d'Hebron University Hospital in Barcelona (Spain) and was attended by a group of international experts on clinical trials from academia, regulatory agencies and industry, encompassing expertise in MASH, cirrhosis, portal hypertension, and regulatory affairs. The presented Roadmap summarizes important content of the workshop on current status, regulatory requirements and end points in MASH-related compensated cirrhosis clinical trials, exploring alternative study designs and highlighting the challenges that should be considered for upcoming studies on MASH cirrhosis.

Translational Aspects of 3D and 4D Printing and Bioprinting.

Three-dimensional (3D) printed medical devices include orthopedic and craniofacial implants, surgical tools, and external prosthetics that have been directly used in patients. While the advances of additive manufacturing techniques in the production of medical devices have been on the rise, clinical translation of living cellular constructs face significant limitations in terms of regulatory affairs, process technology, and materials development. In this perspective, the current status-quo of 3D and four-dimensional (4D) (bio)printing is summarized, current advancements are discussed and the challenges that need to be addressed for improved industrial translation and clinical applications of bioprinting are highlighted. It is focused on a multidisciplinary approach in discussing the key translational considerations, from the perspective of industry, regulatory bodies, funding strategies, and future directions.

Advancing Vaccinology Capacity: Education and Efforts in Vaccine Development and Manufacturing across Africa.

Africa, home to the world's second-largest population of approximately 1.3 billion, grapples with significant challenges in meeting its medical needs, particularly in accessing quality healthcare services and products. The continent faces a continuous onslaught of emerging infectious diseases, exacerbating the strain on its already fragile public health infrastructure. The COVID-19 crisis highlighted the urgency to build local vaccine production capacity and strengthen the health infrastructure in general. The risks associated with a heavy reliance on imported vaccines were exposed during the COVID-19 pandemic, necessitating the need to nurture and strengthen the local manufacturing of vaccines and therapeutic biologics. Various initiatives addressing training, manufacturing, and regulatory affairs are underway, and these require increasing dedicated and purposeful financial investment. Building vaccine manufacturing capacity requires substantial investment in training and infrastructure. This manuscript examines the current state of education in vaccinology and related sciences in Africa. It also provides an overview of the continent's efforts to address educational needs in vaccine development and manufacturing. Additionally, it evaluates the initiatives aimed at strengthening vaccine education and literacy, highlighting successful approaches and ongoing challenges. By assessing the progress made and identifying the remaining obstacles, this review offers insights into how Africa can enhance its vaccine manufacturing capacity to respond to vaccine-preventable disease challenges.

A Review on various aspects of Regulatory Affairs

In order to guarantee the efficacy, safety, and calibre of medications, medical equipment, and other healthcare supplies, Regulatory Affairs is essential. Anticipating future trends and difficulties in Regulatory Affairs is crucial as the healthcare sector changes due to technological breakthroughs, globalization, and new regulatory paradigms. This abstract examines the consequences of developing fields for regulatory frameworks, including gene treatments, digital health, artificial intelligence, and personalized medicine. It also covers the increased significance of real-world evidence, patient-centric approaches, and international harmonization in regulatory decision-making. In addition, it looks at the difficulties presented by supply chain interruptions, cybersecurity risks, and regulatory divergence in a world that is changing quickly. Stakeholders may effectively navigate the complicated regulatory landscape of the future by embracing innovation, collaboration, and adaptive regulatory methods facilitate the timely delivery of safe and effective healthcare products to patients worldwide.

Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products.

Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular vesicles are on the global rise, this paper encompasses different clinical studies registered on clinical-trial register platforms, with varying levels of advancement, highlighting the growing interest in EV-related clinical programs. Navigating the regulatory affairs of EVs poses real challenges, and obtaining marketing authorization for EV-based medicines remains complex due to the lack of specific regulatory guidelines for such novel products. This paper discusses the state-of-the-art regulatory knowledge to date on EV-based diagnostics and medicinal products, highlighting further research and global regulatory needs for the safe and reliable implementation of bioengineered EVs as diagnostic and therapeutic tools in clinical settings. Post-marketing pharmacovigilance for EV-based medicinal products is also presented, mainly addressing such topics as risk assessment and risk management.

Erratum to “Do Regulatory Affairs, Political Stability, and Renewable Energy Demand Improves Environmental Quality? Perceptive from SAARC Region”

Erratum to “Do Regulatory Affairs, Political Stability, and Renewable Energy Demand Improves Environmental Quality? Perceptive from SAARC Region”

Standardized assessment of evidence supporting the adoption of mobile health solutions: A Clinical Consensus Statement of the ESC Regulatory Affairs Committee

Abstract Mobile health (mHealth) solutions have the potential to improve self-management and clinical care. For successful integration into routine clinical practice, healthcare professionals (HCPs) need accepted criteria helping the mHealth solutions’ selection, while patients require transparency to trust their use. Information about their evidence, safety and security may be hard to obtain and consensus is lacking on the level of required evidence. The new Medical Device Regulation is more stringent than its predecessor, yet its scope does not span all intended uses and several difficulties remain. The European Society of Cardiology Regulatory Affairs Committee set up a Task Force to explore existing assessment frameworks and clinical and cost-effectiveness evidence. This knowledge was used to propose criteria with which HCPs could evaluate mHealth solutions spanning diagnostic support, therapeutics, remote follow-up and education, specifically for cardiac rhythm management, heart failure and preventive cardiology. While curated national libraries of health apps may be helpful, their requirements and rigour in initial and follow-up assessments may vary significantly. The recently developed CEN-ISO/TS 82304-2 health app quality assessment framework has the potential to address this issue and to become a widely used and efficient tool to help drive decision-making internationally. The Task Force would like to stress the importance of co-development of solutions with relevant stakeholders, and maintenance of health information in apps to ensure these remain evidence-based and consistent with best practice. Several general and domain-specific criteria are advised to assist HCPs in their assessment of clinical evidence to provide informed advice to patients about mHealth utilization.

A Brief Review on Drug Regulatory Affairs

A Brief Review on Drug Regulatory Affairs

525 A Library-CTSI Collaboration to Support Researcher Compliance with the 2023 NIH Policy for Data Management and Sharing

OBJECTIVES/GOALS: Seeking ways to support teams in the preparation for and the implementation of the new National Institutes of Health (NIH) Policy for Data Management and Sharing (DMSP), the integrated Translational Health Research Institute of Virginia (iTHRIV) partnered with the UVA Health Sciences Library to develop training and resources for researchers. METHODS/STUDY POPULATION: Health sciences librarians and iTHRIV (an NIH-NCATS supported Clinical Translational Research Institute) convened a Working Group, inviting representatives from central and unit-specific research support offices (e.g. the Comprehensive Cancer Center), research compliance, regulatory affairs, sponsored programs, institutional review boards, libraries, and data science to review and discuss the DMSP requirements. After an initial orientation to the policy, the group reviewed existing public resources and solicited feedback about steps to best support UVA researchers in compliance. Leveraging the broad expertise of the group, the team provides guidance to researchers on writing the DMS plan and choosing a data repository, and provides tools and templates to support implementation of the policy. RESULTS/ANTICIPATED RESULTS: A library-created website provided policy guidance, including links to NIH-hosted information, resources created by other institutions, and new UVA-specific templates and suggested proposal language. Librarians led a webinar on the new policy and UVA resources which included a speaker from UVA regulatory affairs to describe the new DMSP requirements, and a tour of the new guide. The guide has been viewed over 5000 times to date and librarians have provided consultations and training to individuals and departments. Current plans include developing a user satisfaction survey, reviewing DMSP feedback from submitted proposals, and incorporating lessons learned into the website and future training. DISCUSSION/SIGNIFICANCE: The collaboration between iTHRIV and the Health Sciences Library to support the NIH Data Management and Sharing Policy was a successful partnership that provided leadership at the institutional level to communicate with and engage researchers and utilized the library’s web presence, expertise, and service model to provide direct support.

The Increasing Demand for Skilled Professionals in the Field of Pharmacovigilance

ABSTRACT The pharmaceutical sector is experiencing rapid advancements in drug discovery, strict regulations, and a commitment to patient safety. This has led to an increased demand for skilled pharmacovigilance experts who can ensure the safety and effectiveness of medicinal products. Several factors contribute to this demand. The expanding pharmaceutical landscape leads to the need for thorough investigation of the safety profile of new medications and treatments. The increasing volume of pharmaceutical products also requires close monitoring for safety and efficacy. Strict regulatory requirements from global agencies further emphasize the need for a robust pharmacovigilance system. The industry’s focus on patient safety drives the demand for professionals who can effectively manage and analyze safety data. The rise of biologics and biosimilars presents additional challenges in monitoring and assessing safety profiles, creating a need for specialized expertise. Furthermore, the globalization of clinical trials and technological advancements, such as artificial intelligence (AI) and machine learning (ML), require experts who can integrate these tools into pharmacovigilance methods. There are certain skill sets that are crucial for pharmacovigilance professionals. These include regulatory knowledge, data analysis and interpretation, case processing, signal detection and risk management, medical and scientific expertise, communication skills, and technological proficiency. There are various career opportunities in pharmacovigilance, including pharmacovigilance officer, pharmacovigilance scientist, medical reviewer, pharmacovigilance team lead/manager, regulatory affairs specialist, and consultant and trainer. Future trends in the field include the convergence of AI and ML, the use of real-world evidence for postmarketing surveillance and drug safety monitoring, collaboration, and outsourcing for PV projects, and the need to tailor pharmacovigilance approaches to personalized medicine. In conclusion, the pharmaceutical industry’s evolution and commitment to patient safety have created a growing need for skilled professionals in pharmacovigilance. Investments in the development and education of these professionals are essential for the advancement of drug safety and public health.

Regulatory requirement for Medical Devices

The safety and regulatory compliance of a widely used medical device have become a growing concern among a significant population. This has raised questions about the assessment of risks, monitoring of adverse drug reactions (ADR), and overall product safety. The efficacy and safety of such medical devices heavily rely on the regulations and guidelines set forth by regulatory agencies (RAs).
 In the pharmaceutical industry, regulatory affairs (RA) professionals play a crucial role in overseeing the lifecycle of healthcare products. They provide strategic, tactical, and operational guidance to ensure compliance with regulations, facilitating the efficient development and delivery of safe and effective healthcare products worldwide. Evaluating adherence to regulations requires a combination of expertise from the business, legal, and pharmaceutical domains.
 Regulatory authorities must thoroughly monitor medical device design, development, and manufacturing processes to guarantee that the products reaching the market are safe and effective. The certification process is intricate, involving multiple steps and the assessment of materials by competent authorities. In the United States, manufacturers must seek marketing authorization from the United States Food and Drug Administration (USFDA) through two primary application types: 510(k) and Pre-Market Application (PMA). In the European Union (EU), national authorities grant permission for the sale of medical devices, employing a third-party compliance system where notified bodies ensure quality assurance pre- and post-approval. In India, the Central Drug Standard Control Organization (CDSCO) licenses devices for sale and import under the CLAA framework.
 Conclusion
 Pharmaceutical regulatory affairs experts play a critical role in ensuring compliance with industry requirements for all pharmaceutical products. This review provides an overview of how medical devices are regulated and monitored in the EU, India, and the USA, emphasizing the importance of regulatory affairs in maintaining the safety and efficacy of healthcare products.

Advanced Applications of Artificial Intelligence in Pharmacovigilance: Current Trends and Future Perspectives

The primary goal of pharmacovigilance, the cornerstone of public health, is to track and evaluate adverse drug reactions in order to guarantee patient safety. Conventional approaches suffer from biases in human error, inefficiency, and scalability problems. A new era in pharmacovigilance is being ushered in by the introduction of artificial intelligence (AI), which holds the promise of vast data analysis, automated procedures, and enhanced safety signal detection. Artificial intelligence technologies improve adverse event detection and signal identification by providing unparalleled speed, accuracy, and scalability. They are adept at applying sophisticated algorithms, machine learning models, and natural language processing to glean insights from unstructured data sources like clinical notes, patient narratives, and regulatory reports. This capacity makes it possible to implement risk management plans that are more thorough and proactive. However, using artificial intelligence in pharmacovigilance necessitates large expenditures for processing power, infrastructure, and regulatory compliance. For artificial intelligence-driven systems to be accurate, dependable, and applicable, ongoing validation, monitoring, and improvement efforts are essential. The ethical and legal implications of patient privacy, data security, and regulatory compliance underscore the necessity of cautious artificial intelligence deployment in order to maintain public trust and protect patient rights. Regulatory agencies, healthcare professionals, and artificial intelligence developers must work together efficiently to implement explainable artificial intelligence frameworks, adaptive surveillance techniques, and improved signal validation processes in order to fully realize the potential of artificial intelligence in pharmacovigilance. This will usher in a new era of proactive risk assessment and improved public health outcomes. Keywords Pharmacovigilance, Artificial Intelligence, Signal Detection, Regulatory Affairs, Patient Safety, Public Health

Overview of Post-approval Submissions Management in US, Europe and Canada

In today’s business era & competition in pharmaceutical industries, post-approval evaluation & cGMP compliance plays an important role. Regulatory approval is a critical milestone in the lifecycle of pharmaceuticals and medical devices, ensuring their safety, efficacy, and quality before entering the market. A regulatory affair is a bridge between pharma industry and health authorities.
 Post-Approval function in Regulatory Affairs department plays a major role in supporting continuous commercialization and facilitating for its implementation. This function are responsible to provide strategic regulatory inputs to plant team on their proposals and to facilitate smooth submission followed by acceptance/ approval. In the USA, the Food and Drug Administration (FDA) governs the regulatory process, employing a thorough and well-defined approach to submission evaluation. Europe, with the European Medicines Agency (EMA) at its helm, utilizes a centralized procedure for marketing authorization, harmonizing regulations across member states. Meanwhile, Health Canada oversees regulatory activities in Canada, emphasizing a risk-based approach to ensure public safety.
 Post-approval submission management is equally vital in maintaining compliance and ensuring ongoing product safety. This paper delves into the strategies and best practices for handling post-approval changes, variations, and renewals. It examines the role of regulatory intelligence, life cycle management, and effective communication with regulatory agencies to navigate the evolving regulatory landscape.
 By comparing and contrasting the regulatory processes in the USA, Europe and Canada, this overview aims to provide valuable insights for pharmaceutical and medical device companies seeking global market access. Understanding the intricacies of regulatory submission and post-approval submission management across these regions is essential for successful product development, commercialisation and long-term regulatory compliance.

Do regulatory affairs, political stability, and renewable energy demand improve environmental quality? Perceptive from the South Asian Association for Regional Cooperation region

The contemporary era confronts formidable obstacles, including environmental deterioration and energy consumption, which jeopardize the rapid advancement of the worldwide financial system. The hazards mentioned above encompass depletion of natural resources, eutrophication, and climatic catastrophes. Within this framework, the discourse surrounding strategic planning centers on institutional positioning and economic prospects, with the incorporation of alternative energy resources serving as a significant metric of economic advancement, as underscored by the COP26 objectives. This research examines the correlation between the quality of institutions and environmental quality, as measured by carbon emissions. A fixed effect regression methodology was utilized to estimate the relationship, utilizing panel data from the South Asian Association for Regional Cooperation economies covering the period from 1990 to 2021. The results show that if there is a 1% increase in the government regulatory quality and renewable energy, carbon emissions decrease by −0.102% and −1.125%, respectively, underscores institutions’ significance in advancing sustainable growth policies within the South Asian Association for Regional Cooperation region. Moreover, if there is a 1% increase in political instability, inbound foreign direct investment, and economic growth, carbon emissions increase by 0.199%, 0.042%, and 0.129%, respectively, suggesting the presence of rent-seeking conduct and pollution haven hypothesis, adversely affecting the ecological system. The study offers significant perspectives for policymakers who aim to foster sustainable regional development.