The US FDA conducts drug manufacturing inspections for facilities to ensure they are compliant with the Current Good Manufacturing Practice (cGMP) standards. However, navigating through these inspections requires a clear and comprehensive understanding of several aspects. These include applicable manufacturing standards, site selection model, 483 forms, and how the FDA reviews the inspections and outcomes. …
Artificial Intelligence in Medicine Regulation– a perspective by Emer Cooke, Executive Director of the European Medicines Agency. Introduction Artificial Intelligence (AI) is revolutionizing the regulation of medicines by offering innovative solutions to enhance drug safety, efficacy, and overall patient well-being. With its ability to process vast amounts of data, identify patterns, and predict potential risks, …
Within the realm of clinical research, the process of obtaining informed consent stands as a crucial cornerstone of ethical practice, serving to protect the rights and well-being of human participants. The U.S. Food and Drug Administration (FDA) recognizes the changing landscape of clinical investigations and the necessity to align with the 2018 Common Rule and …
Guidance on Informed Consent in Clinical Investigations Read More »
The level of scrutiny surrounding animal medicinal products has strengthened more adverse events (AEs) associated with such products have emerged in animals. Indeed, AEs and adverse drug reactions (ADRs) is a cause of concern for veterinarians. Several cases of toxicity from commonly used drugs have been reported, in canines, for example. These include licosamides that …
Understanding the FDA’s Abbreviated New Animal Drug Application Pathway Read More »
The onset of the pandemic amplified an already growing concern in the European Union (EU)- the shortage of medicines, equipment, and devices that subsequently burdens the health system and puts patients at risk. Some of the reasons for these kinds of shortages are related to problems in manufacturing that can delay production, shortages of raw …
Mitigating medical device shortages in public health emergencies Read More »
Technology is rapidly driving the growth of the Pharmaceutical and Life Sciences industries. With digital solutions being made more easily available, drug development & pharmacovigilance are transforming to become more efficient, compliant, and patient safety focused. However, regulatory affairs is still somewhat manual where processes and tasks are repetitive, siloed, and resource-heavy. Though Life Sciences …
Cell, tissue, or gene therapy products (CTGTPs) can contain non-viable or viable human cells or tissues, viable animal cells or tissues, or recombinant nucleic acids and are intended for use in humans to treat, prevent, or even diagnosis conditions that are associated with high treatment burden [1]. However, regulations surrounding CTGTPs vary per region as …
Convergence of regulatory frameworks surrounding cell, tissue, and gene therapy products Read More »
The Russia-Ukraine war has undoubtedly affected millions of people in and around the world. Several industries have taken a huge hit where operational and business continuity has been threatened, pharmaceutical industry being one of them. From the delays along the drug development pipeline, to non-compliance products in the market being at risk, the industry faces …
The impact of the Russia-Ukraine war on clinical trials Read More »
RegTech focuses on technologies that may facilitate the delivery of regulatory requirements more efficiently and effectively than existing capabilities. The global adoption of RegTech is a result of increased regulatory scrutiny, compliance costs, development of artificial intelligence, evolution of data science and increasing demands regarding cost-effective compliance solutions. With ever changing regulatory requirements, pharmaceutical organizations …
DDReg’s RegTech space: your regulatory solution for achieving rapid market access Read More »
Biologic medicinal products, particularly biosimilars, have revolutionized the treatment of chronic conditions. As biologic products lose patent protection, biosimilars emerge as more readily accessible treatment alternatives. In the European Union (EU), the European Medicines Agency (EMA) is responsible for product approval. The EMA was the first regulatory authority to establish a regulatory framework for biosimilars …
Biologics development & regulatory approval – EMA perspective Read More »
