International Journal of Drug Regulatory Affairs

Experience of Health professionals in the implementation of Clinical trials of Traditional Herbal Medicines: A cross-sectional study in Mali

Sat, 15 Jun 2024 00:00:00 +0000

Objective: The objective of this study was to determine the experience of health professionals in clinical trials of traditional herbal medicines in Mali.

Material and methods: This was a cross-sectional study conducted from June to December 2022 among healthcare professionals in three randomly selected localities: the district of Bamako and the regions of Koulikoro and Sikasso. Data were collected by direct interview using an anonymous questionnaire. The Chi-square (χ2) test was used to assess factors associated with participation in clinical trials of traditional medicines.

Results: The involvement of healthcare professionals in clinical trials of traditional medicines was low (3.5%) and was associated with age (p=0.021). The obstacles to conducting these trials reported by healthcare professionals were lack of funding and failure to take account of the specificities of traditional medicines in clinical trial regulations. Some healthcare professionals suggest ethnomedical evaluation of recipes proposed by traditional practitioners and the use of reverse pharmacology as alternatives.

Conclusion: Research into traditional medicines could be given greater impetus by the long-term funding of clinical trials and by less costly alternatives such as the ethnomedical evaluation of recipes proposed by traditional healers and reverse pharmacology.

Regulatory and Quality Compliance of Oncology Products – A Global perspective

Sat, 15 Jun 2024 00:00:00 +0000

The development and manufacturing of oncology products pose unique challenges in ensuring both regulatory compliance and high-quality standards. Oncology products, often complex biopharmaceuticals, play a critical role in cancer treatment, necessitating stringent oversight to safeguard patient safety and therapeutic efficacy. This abstract provides an overview of the key considerations in regulatory and quality compliance within the context of oncology product development.

Regulatory agencies worldwide, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others, have established comprehensive guidelines specific to oncology product development. These guidelines address various stages, from preclinical studies to clinical trials and market approval. Robust regulatory strategies, including well-designed clinical trial protocols and effective interactions with regulatory authorities, are essential to navigate the complex regulatory landscape.

The manufacturing of oncology products demands adherence to strict quality standards to ensure product consistency, safety, and efficacy. Good Manufacturing Practice (GMP) regulations set forth by regulatory agencies require manufacturers to implement and maintain quality systems throughout the entire production process. Quality control measures, including rigorous analytical testing, process validation, and aseptic processing, are crucial components in achieving and maintaining compliance. Oncology products often have unique safety profiles, and risk management plays a pivotal role in regulatory and quality compliance. Comprehensive risk assessments, including identification and mitigation strategies for potential risks, are integral components of regulatory submissions. Post-marketing surveillance and pharmacovigilance programs contribute to ongoing risk assessment and management.

Ensuring regulatory and quality compliance in the development and manufacturing of oncology products is essential for bringing safe and effective therapies to patients. A thorough understanding of regulatory guidelines, implementation of robust quality systems, and proactive risk management strategies are critical elements in navigating the dynamic landscape of oncology product development.

A Review on various aspects of Regulatory Affairs

Sat, 15 Jun 2024 00:00:00 +0000

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.

The Shift Towards Generic Medicine: A Pragmatic Approach by Indian Doctors

Chandra Prakash Sharma, Pankaj Kumar Gogoi, Satyajit Mishra, Pooja Sundriyal — Sat, 15 Jun 2024 00:00:00 +0000

The pharmaceutical industry worldwide has witnessed a significant positive shift in recent years. In India, the discourse surrounding generic medicines has gained momentum, albeit with some challenges. The cost of research and development invested in the development of a drug makes it costly and unaffordable for most of the patients.

The Government of India has made various steps to introduce affordable drugs. However, it has not become very popular amongst patients. Various doubt and lack of confidence among doctors and patients regarding potency, efficacy, and quality is still a concern. There is a need for correct awareness to be spread amongst doctors and patients regarding generic medicine. The pharmaceutical industry also needs to be in the picture and promote positive awareness.

This article aims to shed light on the perspective of Indian doctors as they navigate the complexities of prescribing generic medicines without sufficient government support and limited patient awareness. This article also tries to shed light on the present scenario of how generic medicines are perceived by patients.

A Comparative Study on Regulatory Requirements for Pharmaceutical and Biological Product registration in ASEAN and Asia Pacific Region for Parenteral Dosage Form

Zeel Shah, Maitreyi Zaveri, Shrikalp Deshpande — Sat, 15 Jun 2024 00:00:00 +0000

Regulatory requirements for pharmaceutical and biological product registration varies significantly across different regions impacting availability of critical parenteral dosage form in that market. This thesis provides a comprehensive comparative analysis of regulatory requirements for registration of parenteral dosage form in emerging markets which include ASEAN and Asia – Pacific region.

The study majorly examines key regulatory framework, submission requirement, review process and lifecycle management. Focusing on how these factors affect development and market entry of parenteral product. The research explores major difference in documentation, quality requirements and product life cycle management across these markets. Data for the study is gathered from extensive review of official regulatory documents and guidelines.

Parenteral means ‘Para’ + ‘Enteral’ which means those products that surpasses the intestine and directly enters into systemic circulation. The pharmaceutical parenteral products are derived from synthetic or plant-based API’s whereas biological parenteral products are derived from organisms. This thesis covers all types of parenteral registration requirements including, branded, generic and biosimilar. It includes vaccines, pre-filled syringes, bottles, vials, bags, ampoules, etc.

Aim behind considering RoW market is that they are constantly updating and emerging themselves against regulatory challenges. Some of the countries in these regions have adopted ICH guidelines and others maintain unique regional guidelines. Some countries in region like ASEAN follow ACTD. Few countries like India to reduce the task of handling hard copy have established portals while few have established soft copy submission in CD/DVD or USB form while other still need submission in hard copy.

Regulatory Frameworks for Integrated Medicine Management in USA, Europe, Japan, and China

Sat, 15 Jun 2024 00:00:00 +0000

Integrated Medicine Management (IMM) is an all-encompassing healthcare approach that merges conventional Western medicine with complementary and alternative therapies. The primary objective of IMM is to address the underlying causes of illnesses and promote overall health and wellness of patients. As the utilization of complementary and alternative therapies becomes increasingly prevalent, the need for regulatory frameworks to ensure the safe and effective integration of these therapies into conventional healthcare systems is growing rapidly. Regulatory framework of IMM varies between countries, considering the facts that each country has its own unique approach to manage the integration of complementary and alternative therapies. In this article, we aim to explore the regulatory frameworks for IMM in four major markets, i.e. the United States (US), European Union (EU), Japan, and China. In the US, IMM regulation is centralized among different Federal agencies, however states have varying degrees of oversight. The US Food and Drug Administration (FDA) is responsible for regulating dietary supplements and herbal products, while state medical boards oversee the practice of alternative medicine. Additionally, the National Center for Complementary and Integrative Health (NCCIH) provides research and education on complementary and alternative therapies. Conversely, the regulation of IMM is more centralized in EU, where the European Medicines Agency (EMA) oversees the approval of herbal and homeopathic medicines, and the European Commission provides guidelines for the use of complementary and alternative therapies in healthcare. In Japan, the regulation of IMM is tightly controlled by the Ministry of Health, Labour and Welfare (MHLW), which approves traditional herbal medicines and acupuncture needles, and mandates practitioners to be licensed. China recognizes traditional medicine alongside with Western medicine. The State Administration of Traditional Chinese Medicine (SATCM) oversees the regulation of traditional medicine and promotes its integration with Western medicine.

Dossier submission in the UK after Brexit

Bhavika Patel, Niranjan Kanaki, Bhavik Joshi, Maitreyi Zaveri — Tue, 18 Jun 2024 00:00:00 +0000

The withdrawal of the United Kingdom (UK) from the European Union (EU), commonly known as Brexit, occurred on January 31, 2020, triggering a transition period until December 31, 2020, during which the UK and EU negotiated their future relationship. Brexit has brought significant changes to regulatory frameworks, particularly in the pharmaceutical sector. This article examines the transition of dossier submission procedures in the UK following Brexit, focusing on the implications for marketing authorizations (MAs) and pharmacovigilance. The Medicines and Healthcare Products Regulatory Agency (MHRA) transitioned to an independent regulatory body, establishing new guidelines for pharmaceutical companies seeking MAs in the UK. Key changes in marketing authorization routes include the conversion of centrally authorized products (CAPs) to UK MAs, the introduction of the Decentralized and Mutual Recognition Reliance Procedure (MRDCRP), and the implementation of a 150-day assessment timeline for national procedures.

This article compares dossier requirements before and after Brexit in the UK and highlights pharmacovigilance requirements post-Brexit, emphasizing adjustments to reporting obligations, Qualified Person for Pharmacovigilance (QPPV) responsibilities, and the establishment of UK-specific Pharmacovigilance System Master Files (PSMFs). Additionally, it addresses the dossier Module 1 administrative information requirements to provide a comprehensive overview of the changes in regulatory procedures in the UK pharmaceutical sector following Brexit.

Overall, the article aims to serve as a valuable resource for industry professionals, regulatory experts, and other stakeholders seeking clarity on the regulatory changes and their implications for pharmaceutical products in the UK following Brexit.

Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines

Devanshi Shah, Vinit Movaliya, Shruti Kharidia, Maitreyi Zaveri — Sat, 15 Jun 2024 00:00:00 +0000

Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature.

Summary: In the pharmaceutical industry, ensuring the quality, safety, and effectiveness of medicinal products is of utmost importance. Analytical Method Validation (AMV) and Process Validation (PV) are critical procedures in pharmaceutical manufacturing, vital for upholding product quality and adhering to regulatory standards. This thesis undertakes a comparative examination of AMV and PV guidelines from prominent regulatory authorities, including the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the European Medicines Agency (EMA), the World Health Organization (WHO), and the Association of Southeast Asian Nations (ASEAN).

The study delves into the foundational principles, methodologies, and regulatory requirements outlined by each guideline to assess their alignment and differences. It scrutinizes key aspects such as validation parameters, acceptance criteria, documentation requirements, and statistical approaches to identify commonalities and disparities among the guidelines. Furthermore, this research aims to offer insights into the practical implications of adhering to multiple regulatory frameworks concurrently. It examines the challenges pharmaceutical companies encounter in navigating divergent requirements and harmonizing validation processes across various regions. Additionally, potential strategies to streamline compliance efforts and optimize resource allocation are explored.

By synthesizing the findings of this comparative analysis, stakeholders in the pharmaceutical industry can gain a comprehensive understanding of the regulatory landscape governing AMV and PV practices. Moreover, the insights derived from this study can inform the development of harmonized validation protocols that facilitate global market access while maintaining the highest standards of product quality and patient safety.

Conclusion: Notable variations exist in validation approaches, but all emphasize product quality, safety, and efficacy. Pharmaceutical companies must navigate diverse regulatory landscapes for compliance.

Overview and Lifecycle Management of Generic Pharmaceutical Drugs in Mexico, Guatemala and Brazil

Helly Kuveria, Zuki Patel, Manvendra Raval, Maitreyi Zaveri — Sat, 15 Jun 2024 00:00:00 +0000

Objective: The generic pharmaceutical markets in Mexico, Guatemala, and Brazil are influenced by distinct regulatory frameworks, production and distribution dynamics, and marketing strategies, which shape lifecycle management. Regulatory policies, market competition, and healthcare initiatives impact accessibility, affordability, and quality, presenting both challenges and opportunities for enhancement in these areas.

Summary: This thesis offers an in-depth examination of lifecycle management strategies in the generic pharmaceutical markets of Mexico, Guatemala, and Brazil. Generic drugs are crucial for increasing access to affordable healthcare, especially in emerging economies. Through comparative analysis, this research explores the regulatory frameworks, market dynamics, and key challenges in the development, approval, marketing, and post-marketing surveillance of generic drugs in these three Latin American countries.

The study starts with an overview of the regulatory landscape for generic pharmaceuticals in Mexico, Guatemala, and Brazil, highlighting similarities and differences in registration requirements, approval processes, and post-approval obligations. It investigates the roles of regulatory agencies like COFEPRIS, DIGEMID, and ANVISA in ensuring the quality, safety, and efficacy of generic drugs throughout their lifecycle. Additionally, the research delves into the strategies used by pharmaceutical companies for lifecycle management of generic drugs, including variations, biowaivers, and labeling changes.

Real-world case studies illustrate post-approval changes and their regulatory implications in each country, providing insights into the complexities of managing generic drug portfolios in different regulatory environments. The thesis also examines the market dynamics affecting the availability, pricing, and accessibility of generic drugs in Mexico, Guatemala, and Brazil. Factors such as patent expirations, competition, healthcare policies, and public procurement practices are analysed to understand their impact on market entry, competition, and the affordability of generic drugs. Furthermore, the study addresses the challenges and opportunities in pharmacovigilance and post-marketing surveillance of generic drugs, emphasizing the need for robust systems to detect and manage adverse drug reactions and ensure patient safety.

Conclusion: The key findings highlight regulatory frameworks, market dynamics, and lifecycle management strategies in the generic pharmaceutical markets, identifying challenges and opportunities. The study reflects on implications for stakeholders and suggests areas for future research to enhance accessibility, affordability, and quality.

OTC drug filing and review process in the US

Priyal Nayi, Maitreyi Zaveri, Dhaval Sheth, Niranjan Kanaki — Sat, 15 Jun 2024 00:00:00 +0000

The Over-the-Counter (OTC) Drug Monograph System in the United States (US) serves as a vital regulatory framework for non-prescription medications. Through the monograph review process there is a low regulatory burden for industry to market OTC drugs and that helps to keep OTC drug costs low to consumers. As, this process is applicable only in the US the OTC drug filing and review process becomes streamline and due to its limited time exposure this process is not time consuming.

There are mainly two pathways to bring a OTC drug in the US: (a) NDA, (b) OTC drug review process. By comparing both the procedures NDA submission is time consuming process and as of that for OTC review process, if drugs meet the conditions specified in the monograph OTC drug can be marketed in a more streamline process. Administrative order process provides sponsor or requestors and the FDA to issue an order. As, the three phase rulemaking process is removed after the enactment of CARES act, the OTC monograph reform encountered several challenges and is beneficial. OTC Monograph System, serves as a cornerstone for ensuring the accessibility, safety, and efficacy of a diverse range of OTC drugs.

The proposed study is based on review process for various OTC monograph drugs. This research is focused on the regulatory pathway that facilitates the approval of non-prescription medications, the study explores the historical evolution and current functioning of the OTC Monograph System.