International Journal of Drug Regulatory Affairs

Analysis of the conditions for the creation of pharmaceutical university spin-offs within a public university in Burkina Faso

2024-03-18T15:18:35+00:00

This study aimed to analyze the legal framework for the creation of university spinoffs, particularly those in the fields of medicine and pharmacy in Burkina Faso. This was carried out through a literature review, supplemented by interviews with resource persons from the sectors in charge of commerce, industry, finance, scientific research and innovation, health, and youth.

In Burkina Faso, there are no specific provisions for promoting university spinoffs. A Simplified Joint Stock Company is the most appropriate legal form for these types of companies. Moreover, these laws do not favor the mobility of researchers in entrepreneurship. In addition, university spinoffs are subject to the same tax pressure as conventional companies. Nevertheless, the University of Joseph KI-ZERBO supported project leaders through its incubator. However, its lack of status, insufficient material, and financial resources limit its actions.

Quality of examination gloves in health facilities in Addis Ababa, Ethiopia

2024-03-18T17:12:35+00:00

Background: Examination gloves are used in health facilities to protect health professionals and patients from the risk of infection and reduce opportunities for cross-transmission of infectious microorganisms. Poor-quality examination gloves can expose health professionals to infectious diseases such as Covid-19, Hepatitis, HIV/AIDS, and other contagious diseases. Hence, this study aimed to assess the quality of examination gloves in health facilities in Addis Ababa.

Methods: A cross-sectional study design was employed. The examination gloves were collected from randomly selected health facilities in Addis Ababa. The gloves were examined following standard procedure in the Ethiopian Food and Drug Authority. Holes in the examination gloves were detected using the watertight (leakage test) and geometrical dimensions such as thickness, width, and length were measured.

Results: A total of 2500 selected examination gloves were collected between Feb 10 and Feb 20, 2021. The gloves were sampled from health facilities in Addis Ababa. From the total samples collected, only 2280 examination gloves of five different brands were tested, which makes the response rate 91.2%. The proportion of gloves with holes detected ranged from 5.7% to 21.9%. Overall, only 0.17% and 3.2% of the gloves had width and length below standard, respectively. None of the gloves tested in this study had a thickness below the standard.

Conclusions: All brands of examination gloves tested had a higher hole (leakage) rate than the acceptable quality limit. This implies there is a substantial risk of infectious disease transmission to health professionals and patients in healthcare settings. Hence, regulatory enforcements need to be strengthened across the life cycle of the product.

Nitrosamine Contamination in Pharmaceuticals: Regulatory Perspectives and Control Strategies of USFDA, EMA & HC

2024-03-30T03:21:00+00:00

Various regulatory authorities were notified the presence of nitrosamine impurities in human medicines including angiotensin II receptor blockers (ARBs), ranitidine, nizatidine and metformin in 2018. The presence of nitrosamines led manufacturers to assessed their products by any means that might inadvertently lead to nitrosamine content and taking steps to mitigate these risks after issuance of safety alerts, recall and withdraw certain batches of these drugs. Importantly, global cooperation by regulatory authorities triggered the investigation of synthetic route, rapid development of analytical procedures and publication of guidelines. This article highlights mainly on risk assessment and control strategies adopted by United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA), and Health Canada (HC) regulatory bodies. Additionally, compare the acceptable intake (AI) values recommended by these regulatory authorities which will help the manufacturer to either limit or eliminate nitrosamines impurities in their medicines because nitrosamines are probable or possible human carcinogens, hence, it is recommended that the potential causes of nitrosamine formation as well as any other pathways observed and evaluate the risk for nitrosamine contamination or formation in their APIs and drug products. Manufacturers should prioritize evaluation of APIs and drug products based on factors such as maximum daily dose, duration of treatment, therapeutic indication, and number of patients treated for the products which are under pre approval stage and already marketed products.

Conclusion:

As nitrosamine contamination affects patients worldwide, in case the levels of nitrosamines exceed acceptable limits, or more than one nitrosamine is observed, such products should not be commercialized. All the international regulatory agencies continuing to work with to propose various analytical methodologies to determining nitrosamine content in the API or FPP, risk assessment evaluation and control strategies, extrapolation of toxicological data and various confirmatory test for mutagenicity detection. Due to this rapid action taken by global authorities will help manufacturer to design their manufacturing process to be more robust so that they will timely register their products and reduce the additional cost require for its complete analysis by taking care of consumer’s safety as well.

Regulatory requirement for Medical Devices

2024-03-30T04:36:57+00:00

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.

Drug Recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023

2024-03-19T16:47:53+00:00

With the advanced technologies, increasing complexities of the manufacturing processes, more stringent inspections, and dynamic regulatory environment under which manufacturers work, there are high possibilities that a pharmaceutical firm will undergo a recall of one of its products. A recall can impact a company in product exposure, sales, manufacturing costs, and patients trust. The study presented here explored the drug recalls made by Indian Pharmaceutical Industry during the period of 2013 – 2023. There is an increasing trend in number of recalls post 2017 which could be due to the new regulations and, scientific discoveries. The major reasons for recalls primarily included cGMP deviations, failure to comply with approved specification, labeling mix ups. The study enlists the expectations of US FDA from Indian Pharmaceutical sector. This will help Indian pharmaceutical manufacturers to adopt the strategies to minimize drug recalls.

Dosage form Design: From concept to Compliance - Navigating Regulatory Standards and Patient needs

2024-03-30T04:45:51+00:00

Dosage form design is a pivotal aspect of pharmaceutical formulation, encompassing the meticulous crafting of pharmaceutical products to ensure efficacy, safety, and patient acceptance. This paper comprehensively explores dosage form design, delving into its definition, significance, and multifaceted roles in pharmaceutical development. From therapeutic considerations and biopharmaceutical factors to patient compliance and convenience, every facet of dosage form design is meticulously examined. Therapeutic considerations underscore the need for controlled drug release profiles, optimal bioavailability, precise dosing, and route-dependent administration to maximize therapeutic outcomes and minimize adverse effects. Biopharmaceutical factors, such as drug solubility, permeability, dissolution rate, and absorption site, shape dosage form design strategies to enhance drug performance and bioavailability. Moreover, patient compliance and convenience are pivotal in ensuring adherence to treatment regimens, with considerations ranging from dosage frequency and taste to packaging and patient education. Furthermore, this paper elucidates the intricate interplay between dosage form design and regulatory compliance, emphasizing the importance of adhering to rigorous standards to uphold patient safety and efficacy. By synthesizing theoretical insights with practical applications, this review elucidates the comprehensive approach required for effective dosage form design, encompassing scientific rigor, regulatory adherence, and patient-centric considerations.

Conclusion

This paper underscores the paramount importance of dosage form design in pharmaceutical development, serving as a cornerstone for optimizing therapeutic outcomes, ensuring patient adherence, and advancing public health initiatives. Through a nuanced understanding of dosage form design principles and their implementation, pharmaceutical scientists and healthcare professionals can forge a path toward innovative drug delivery solutions that transcend conventional boundaries and empower patients to achieve optimal health outcomes.

The Regulatory Affairs Automation tools used in the Pharmaceutical Industry: An overview

2024-03-18T14:28:55+00:00

Automation is becoming increasingly prevalent in various industries, including healthcare and pharmaceuticals. The pharmaceutical business is influenced by a variety of worldwide trends, with one of the most significant being the use of automation technologies, which will have a transformative effect on the research and development of new pharmaceutical products as well as the speed and efficiency with which products reach patients in need. Regulatory automation is enabled by a variety of technology tools, such as Electronic Document Management Systems, Regulatory Information Management (RIM) Systems, Artificial Intelligence (AI) Analytics Tools, Natural Language Processing (NLP) Tools, and Submission Publishing Tools. Automation tools can be used to automate regulatory activities such as administrative work, dossier completion, data extraction, auditing, regulatory implementation as well as quality management. Automation tools establish process links and minimize complexity, resulting in a more efficient management system. Human-AI interaction creates new prospects in regulatory concerns. This article investigates the potential use of automation techniques in pharmaceutical regulatory concerns.

Technical reasons for delay and denial of regulatory approval of Initial applications for (Abbreviated) New Drugs filed by Indian Companies by USFDA, 2005-2022

2024-03-24T04:15:41+00:00

Indian pharmaceutical companies are one of the leading sources of generic medicine to the United States. The US Food and Drug Administration (US FDA) conduct regular inspections and assessments of manufacturing facilities in order to confer product quality and to ensure a firm's compliance with applicable laws and regulations, such as the Food, Drug and Cosmetic Act and related Acts. Identified regulatory violations and noncompliance are notified by US FDA to the manufacturer in the form of 483s and warning letter. Warning letters led to the unfavourable consequences to the company such as loss of trust, reputation and affects their financial stability. A trend analysis of warning letters may help Indian pharmaceutical manufacturing companies to adopt cGMP practices as per the requirement of US FDA and thus will result in reduced number and frequency of warning letters. Therefore, a trend analysis of warning letters issued to Indian Pharmaceutical sector between 2005 till 2022 by US FDA was carried out by extracting the information from publicly available FDA archives and dashboard. There is an increasing trend in number of US FDA inspections in India post 2012 which could be due to the new regulations, updated laws, also the changed expectations and mindset of FDA inspectors. The FDA major findings included inadequate investigations systems, lack of authoritative quality units, product contamination and inadequate documentation practices. The study reported here enlists the expectations of US FDA from Indian Pharmaceutical sector. This will help Indian pharmaceutical manufacturers to adopt the strategies to minimize US FDA warning letters.

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

2024-03-28T02:23:30+00:00

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.

Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU)

2024-03-28T02:27:39+00:00

The market for biotechnology-derived medicinal products is evolving rapidly with the imminent entry of biosimilars. The development and approval of biosimilars represent a critical pathway to expanding access to biological therapies while maintaining high standards of safety, efficacy and immunogenicity profile because biosimilars are made in living organisms there may be some minor differences from the reference medicines.

In the US, biosimilars are regulated under the Biologics Price Competition and Innovation Act (BPCIA), which is part of the Affordable Care Act. The regulatory pathway emphasizes a stepwise approach, involving analytical studies, preclinical assessments, and comparative clinical trials to establish biosimilarity with a reference product. The FDA assesses the totality of evidence provided by the biosimilar applicant to make a determination on safety, purity, and potency.

In the EU, the approval process for biosimilars is governed by the European Medicines Agency (EMA). The regulatory framework relies on a robust comparability exercise, emphasizing extensive analytical studies and well-designed clinical trials to establish biosimilarity. The EMA assesses the comprehensive data package submitted by the biosimilar applicant, considering the totality of evidence before granting marketing authorization.

While the overall approach is similar, there are nuanced differences in the regulatory processes. The US typically requires a more prescriptive approach to clinical trials, with the expectation of conducting at least one confirmatory comparative clinical trial. In contrast, the EU may allow for a more tailored approach to clinical development, recognizing that the need for extensive clinical trials may vary depending on the nature of the biosimilar and the reference product.

As the biosimilar landscape continues to evolve, ongoing collaboration and harmonization efforts between regulatory authorities aim to streamline global access to high-quality ,cost-effective biologic therapies.