Point of Care Manufacturing and Regulatory Considerations

Description

This presentation by Ian Rees introduces the topic of point of care manufacture in the context of healthcare. Rees begins by sharing his background as a GMP inspector and his role in supporting the Innovation Office at the MHRA, with the office receiving around 1,400 inquiries since its inception in 2013. He emphasizes the unique characteristics of point of care manufactured products, notably their extremely short shelf life—ranging from a few hours to as little as 30 seconds—necessitating their production close to or within healthcare settings instead of traditional factories.



Rees discusses a variety of products that fall under this category, including medicinal gases, blood-type products, and advanced therapy products such as cell and gene therapies. He clarifies the regulatory considerations, differentiating between non-regulated transplants and regulated products requiring significant manipulation. The proposed point of care framework aims to establish a control site overseeing the manufacturing activities, ensuring these products meet the same safety, quality, and efficacy standards as conventional medicinal products, even though they will not be marketed in the same way.



The presentation outlines the current state of consultations, ongoing stakeholder engagements, and the legislative process required to implement this new framework, forecasting the development timeline over the next few months and anticipating legislative changes to be finalized by the second quarter of the following year. Rees concludes with a commitment to ongoing collaboration with stakeholders to fine-tune the framework to ensure it effectively meets the needs of modern healthcare.

Specialties