Journal Articles related to Regulatory Affairs and CMC
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This article assesses some of the most notable clinical developments in recent years, where the next generation of research is likely to be heading in the coming years, how the regulatory authorities are responding to these advances, and how these developments and regulatory proposals are likely to impact patient access.
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Regulators are tightening their scrutiny of the trial master file (TMF), placing the onus on companies to be ready for evaluation. Inspection-readiness should be embedded from the beginning, rather than a reaction to a notice of an inspection.
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The eCTD v4.0 standard has been available to be used for submissions to any ICH-participating regulatory agency since 2015, when it reached Step 4 in the International Council on Harmonisation (ICH) process. However, 10 years later, only Japan and the US have begun optional use of the new version.
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Combination-product growth has surged globally as both physicians and patients request fewer invasive procedures in favor of user-friendly treatment delivery options.
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Advances in the cancer treatment space have renewed hope for breakthroughs with personalized cancer vaccines (often also called personalized immunotherapies). More recently, there have been promising results in a number of areas, including pancreatic cancer, melanoma, and non-small cell lung cancer (NSCLC).{1} According to analysts, significant growth is expected for cancer vaccines, with one report noting that the global market for cancer vaccines should grow from $10.21 billion in 2023 to $30.16 billion by the end of 2033.{2}
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While regulatory authorities are increasingly adopting reliance programs to asses applications, few offer the opportunity to take advantage of simultaneous assessment and approval timelines across borders and jurisdictions.
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The electronic Common Technical Document (eCTD) is 16 years old, approved by the International Council on Harmonisation (ICH) to Step 4 in 2008. It’s old enough to drive a car in the US. It’s had some small changes over the years but is still pretty much the same as it was in the George W. Bush era. It’s had a huge impact on the speed and accuracy of regulatory submissions for pharma … but it could be better. That same year, the US Food and Drug Administration (FDA) started looking at a next-generation submission format, which would become eCTD 4.0. That standard
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Health authorities are turning to digitalization to streamline their processes in response to global crises (such as the COVID-19 pandemic) that have affected the supply chain. The growing complexity of information and data in regulatory submissions has encouraged health authorities to implement structured data submissions and centralized e-submission processes through shared workspaces (1, 2). Some ongoing initiatives seek to simplify review and assessment processes through increased global cooperation and harmonization.
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Development of cell and gene therapy (CGT) products is often challenged by the need to demonstrate product comparability following changes in the manufacturing process. Issues include limited process and product knowledge at different stages of product development compared to more conventional biotherapeutics, the complex mechanism of action, the limited and sometimes variable nature of the starting materials, and analytical methods which are often still in development during a comparability study.
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Shifting to a digital regulatory environment is forcing pharmaceutical companies to confront knowledge gaps across key research and development (R&D) functions.
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Effective change management systems ensure that innovation and continual improvement are facilitated, that change is appropriate and proportionate, and that key personnel take a level of ownership of the change. Processes related to change management must include an understanding of the current state and a vision for the future state.
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Efforts to improve the regulatory review process through standardization, harmonization, and digitalization have gathered steam in recent years with regulators and industry alike pushing forward with data-driven initiatives. Guest contributors from PharmaLex discuss what these mean for 2023 and beyond.