Industry Perspective - A New Regulatory Framework for Innovative Products Manufactured at or Close to the Point of Patient Care

The pharmaceutical and Medtech industries prioritize public health by ensuring the quality, safety, and efficacy of medicines. With an increasing product portfolio and advanced modalities, the industry faces significant challenges, including economic pressures, regulatory compliance, and ethical concerns. Keeping in view the manufacturing of new innovative medicines and to accelerate time to market and facilitate patient access, the Medicines and Healthcare products Regulatory Agency (MHRA), UK, has introduced an innovative regulatory framework for point - of - care (POC) manufacturing of advanced therapies, including cell and gene therapy, 3D - printed products, and medicinal gases. This framework promotes patient - centricity, cost reduction, supply chain efficiency, environmental sustainability, and the delivery of high - quality personalized treatments. Despite its benefits, the framework necessitates rigorous scrutiny, robust training, and effective knowledge management. By fostering collaboration and leveraging modular technology, it aims to transform the manufacturing landscape, ensuring rapid access to innovative therapies and enhancing local economies.