Clinical Regulatory

Cancer continues to be a major cause of mortality around the world, highlighting the urgent need for innovative strategies to deliver life-saving treatments to patients. In this pursuit, U.S. Food and Drug Administration (FDA) launched an initiative called Project Orbis in 2019, to transform the global regulatory framework for oncology drugs. Project Orbis has showcased […]

Bioequivalence (BE) assessment is pivotal for determining the therapeutic equivalence of generic drug products to their respective reference-listed drugs (comparator products). The BE study should be conducted according to the guidelines set up by the U.S. Food and Drug Administration (FDA). One such guideline “M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms” is a set

In recent years, the pharmaceutical industry has been under increasing pressure to improve transparency, particularly when it comes to sharing clinical trial data. As the demand for open access to clinical research grows, regulatory bodies are stepping up to ensure that public health decisions are made based on comprehensive, accessible information. The European Medicines Agency

The Advanced Therapy Medicinal Products (ATMPs) regulation was and covers gene therapy, somatic cell therapy, and tissue-engineered products. The ATMP’s requirements for the development, manufacturing, approval, and post-marketing surveillance for these products are regulated under regulation (EC) No. 1394/2007 and Directive 2001/83/EC in the European Union (EU). Stringent regulatory agencies, like the European Medicines Agency

In recent years, the emphasis on diversity in clinical trials has become more prominent, reflecting the need for studies on more diverse populations to gather more accurate clinical findings. The lack of diversity in participants can create an obstacle to understanding the safety and efficacy of new medicines, making it more difficult to understand the

The journey from discovering a promising compound to its approval as a safe, effective drug is challenging and costly, involving rigorous clinical trials to ensure public health and patient safety. The European Union responds to the need for speed and efficiency by transforming how clinical trials are conducted. The Accelerating Clinical Trials in the EU

Since 2004, clinical trials (CTs) in the European Union (EU) have been governed by the Clinical Trials Directive (CTD) 2001/20/EC. This directive aims to harmonize the administrative requirements governing CTs across EU Member States. Each Member State (MS) has its own set of procedures, requirements, and timelines for CT operations. However, there was a need

Imagine a pharmaceutical company about to launch a new drug. Clinical trials have shown promising results, but the real test lies in how this drug will perform in the hands of thousands—or even millions—of patients in the real world. Will it be as effective? Will unexpected safety issues arise? The answers to these questions often