Nagalakshmi S*, Sangeetha Priya S and Aravind R
DOI: 10.37421/2167-7689.2023.12.358
Software is revolutionizing how doctors practice medicine, customers control their health, and patients and providers interact. Software that can perform advanced medical functions software as a medical device is a game-changing innovation in digital health technology (SaMD). SaMD may diagnose ailments, prescribe medications and offer clinical treatment recommendations. The US FDA, EU and Australia TGA also specified general platforms. To overcome the challenges while interpreting software product fits into the medical device framework, IMDRF has developed different guidance including risk based categorization to determine possible levels of premarket reviews and Real-World Evidence (RWE).) IMDRF plays a similar function in enabling the regulators to risk-stratify submissions and focus resources on products that pose the greatest risk to patient safety. While SaMD products are not new, there are many new players in the SaMD space to better regulate iterative devices. One of the key goals is to identify the excellence of the SaMD Regulatory paradigm regulation of these products will need to radically change to accommodate new SaMD manufacturers and the technology’s rapid evolution and to harness SaMD’s ability to capture RWD to create a collaborative, innovative SaMD community. This review aimed to describe the regulatory and technical aspects of the software as a medical device and regulatory transformation of digital health rapidly expanding regulations by different health authorities.
Patel Hetvi*, Shah Krutarth and Joshi Yash
DOI: 10.37421/2167-7689.2023.12.359
Generic drug products played an important role in the health care system in global aspects especially in the middle income country and fully developed country. They play important role in the lowering the cost of medicine and provide the low cost treatment in targeted countries. Generic drugs have the same therapeutic value same as the innovator product. This study aims to achieve the comparison of the regulation of generic drug product regulation in Zimbabwe, USA, Canada and Europe. All of the targeted countries follows the common technical document format and also focuses on safety quality and efficacy of the drug product. Regulation of generic drug in Zimbabwe is easy compared to rest of the countries.
DOI: 10.37421/2167-7689.2023.12.368
DOI: 10.37421/2167-7689.2023.12.369
Pharmaceutical compounds are a class of chemical substances that are specifically designed to treat; activated sludge is a popular wastewater treatment process that has been used for decades to remove a variety of pollutants from municipal and industrial wastewaters. This process involves the use of a mixture of microorganisms to break down organic matter in the wastewater, converting it into carbon dioxide, water, and other substances that are less harmful to the environment.
Pharmaceuticals are a class of emerging contaminants that have been increasingly detected in wastewater treatment plants around the world. These compounds, which include antibiotics, analgesics, hormones, and other drugs, are not completely removed by conventional wastewater treatment processes, including activated sludge. Several studies have investigated the removal of pharmaceuticals in activated sludge, and while the results are promising, the process is complex and depends on several factors. In this article, we will discuss the various factors that affect the removal of pharmaceuticals in activated sludge and the mechanisms involved in the process.
Several factors can affect the removal of pharmaceuticals in activated sludge, including the type of pharmaceutical, the concentration of the pharmaceutical, the Hydraulic Retention Time (HRT), the temperature, and the presence of other organic matter in the wastewater.
Different pharmaceuticals have different chemical structures, and this can affect their removal in activated sludge. For example, compounds with high hydrophobicity, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and some antibiotics, are often poorly removed by activated sludge due to their low solubility in water.
DOI: 10.37421/2167-7689.2024.13.405
DOI: 10.37421/2167-7689.2023.12.370
DOI: 10.37421/2167-7689.2023.12.371
DOI: 10.37421/2167-7689.2023.12.383
DOI: 10.37421/2167-7689.2023.12.384
DOI: 10.37421/2167-7689.2023.12.385
DOI: 10.37421/2167-7689.2023.12.386
Pharmacy, as a crucial discipline within the healthcare system, has experienced significant evolution and development over the years. This comprehensive field encompasses various domains, including the discovery, production, and distribution of medications, patient care, and medication management. In this article, we will explore the dynamic nature of pharmacy, its vital role in modern healthcare, and the evolving responsibilities of pharmacists in providing optimal patient outcomes. The origins of pharmacy can be traced back to ancient civilizations, where medicine and pharmaceutical practices were intertwined.
DOI: 10.37421/2167-7689.2024.13.398
Regulatory compliance is a critical aspect of the pharmaceutical industry that ensures the safety, efficacy, and quality of drugs. The complex and evolving nature of regulations poses challenges for pharmaceutical companies, making compliance a top priority. This research article aims to demystify regulatory compliance in the pharmaceutical industry by providing an overview of key regulations, highlighting the challenges faced by companies, and discussing strategies to achieve and maintain compliance. By understanding the regulatory landscape and implementing effective compliance measures, pharmaceutical companies can navigate the regulatory framework more efficiently and ensure the delivery of safe and effective medicines to patients.
DOI: 10.37421/2167-7689.2024.13.399
Pharmaceutical regulatory affairs play a crucial role in ensuring the safety, efficacy, and quality of drugs in the market. With the ever-evolving landscape of the pharmaceutical industry, regulatory agencies continuously update their guidelines and requirements. This research article aims to explore the latest trends and updates in pharmaceutical regulatory affairs, highlighting key developments in areas such as drug approvals, post-marketing surveillance, data integrity, and emerging technologies. A comprehensive understanding of these trends is vital for pharmaceutical companies, regulatory professionals, and other stakeholders to stay compliant and foster innovation in the industry.
Pharmaceutical regulatory affairs are constantly evolving to adapt to the changing landscape of the industry and ensure the safety and efficacy of drugs. This research article explores the latest trends and updates in pharmaceutical regulatory affairs, covering areas such as drug approvals, post-marketing surveillance, data integrity, and emerging technologies. The article emphasizes the importance of staying informed about these trends to ensure compliance, foster innovation, and contribute to the development of safe and effective pharmaceutical products. By understanding these updates, pharmaceutical companies, regulatory professionals, and stakeholders can navigate the regulatory landscape more effectively and contribute to the advancement of the industry.
DOI: 10.37421/2167-7689.2024.13.400
The pharmaceutical industry operates in a highly regulated environment, where adherence to various regulatory requirements is essential to ensure the safety, efficacy, and quality of drugs. Regulatory Affairs (RA) professionals play a crucial role in navigating the complex landscape of pharmaceutical regulations, which are subject to continuous evolution. This article provides an overview of the key aspects of pharmaceutical regulatory affairs, including drug development, regulatory submissions, clinical trials, post-marketing surveillance, and global harmonization efforts. It explores the challenges faced by regulatory affairs professionals and highlights strategies to effectively manage compliance and ensure successful regulatory outcomes.
The primary objective of pharmaceutical regulatory affairs is to safeguard public health by ensuring that pharmaceutical products meet the highest standards of safety, efficacy, and quality. Regulatory affairs professionals work diligently to ensure that drugs undergo rigorous testing, meet regulatory requirements, and gain approval for marketing and distribution.
DOI: 10.37421/2167-7689.2024.13.401
Regulatory affairs play a crucial role in safeguarding public health by ensuring the safety, efficacy, and quality of pharmaceutical products. This research article explores the multifaceted responsibilities of regulatory affairs professionals in the drug development process. It examines their role in navigating the complex regulatory landscape, fostering compliance with evolving guidelines, and facilitating communication between various stakeholders. The article also highlights the significance of regulatory affairs in promoting innovation, addressing global harmonization efforts, and fostering public trust in the pharmaceutical industry. Overall, this research emphasizes the critical role regulatory affairs plays in maintaining drug safety and efficacy throughout the product lifecycle.
DOI: 10.37421/2167-7689.2024.13.402
DOI: 10.37421/2167-7689.2024.13.403
DOI: 10.37421/2167-7689.2024.13.404
DOI: 10.37421/2167-7689.2024.13.406
DOI: 10.37421/2167-7689.2024.13.407
The submission of regulatory information to health authorities is a critical process within the pharmaceutical, biotechnology, and life sciences industries. To streamline this process, various standardized formats and specialized software solutions have been developed. These tools ensure compliance with international regulatory standards, facilitate efficient document management, and enhance submission accuracy. Below is an overview of common submission formats and the leading software tools used in regulatory processes.
The latest version of EU GMP Annex 1 was approved in August 2022 after a very long period of discussions [1]. People can expect that regulatory innovations are steps forward in quality assurance of medicinal products. But is it really so? Many presentations describe changes as to be progressive without explaining in depth. If to do so, one can see huge confusions in Annex 1 regarding requirements for cleanrooms. It is a pity that those who made changes ignored results of investigations [2,3], that were submitted to EU GMP Commission. New confusions were added to old contradictions and dogmas. A look in depth allows to understand whether changes are positive or they even jeopardize quality of products.
Sonia Tanwar and Anshuman Panchal*
In India, CDSCO controls all the activities related to importing, exporting, manufacturing, warehousing, and selling drugs, biologics, and medical devices. The CDSCO's intention to expedite the evaluation and licensing of a COVID-19 vaccine was announced in the Vaccine Notice, which was released at the start of the pandemic. After getting authorization from the CDSCO, the hospitals/medical institutions may import or produce the unapproved medicine as long as the unapproved drug is undergoing Phase-III clinical trials in India or elsewhere. CDSCO issued a notice regarding the launch of the online platform for adverse event reporting of medicines through the SUGAM portal. Under extraordinary circumstances, the CDSCO may only modify the eligibility criteria for importing drugs with a shorter shelf life if they have not passed their expiration date. Manufacturers of medical devices are no longer required to seek a manufacturing or import license before manufacturing or importing the regulated devices under the medical devices compliance orders. India's leading drug regulatory authority CDSCO permitted Covaxin and Covishield vaccines developed by Bharat Biotech Ltd. and Serum Institute of India Ltd., respectively, for restricted use in an emergency. The Subject Expert Committee's recommendations grant authorization for restricted use in emergencies ("SEC"). Manufacturers of vaccines in India must supply at least 50 percent of vaccines to the Government of India to fulfil the demand. In this review, most of the regulatory guidelines related to the import, export, manufacture, warehouse, and sale of drugs, biologics, and medical devices, especially related to COVID-19, have been discussed.
Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
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