2021-08-18 11:33:04
The MHRA is conducting a consultation on Point of Care (“POC”) manufacturing https://www.gov.uk/government/consultations/point-of-care-consultation/consultation-on-point-of-care-manufacturing
According to the MHRA, new types of innovative products are increasingly being manufactured at the point where a patient receives care, eg personalised medicines made for the patient either within or very close to the healthcare setting. Technology enables the creation of new types of medicinal product that have features such as very short shelf lives, unlike typical current products with shelf lives measured in years. Medicines regulation supports the latter, geared to manufacture in factories for global distribution. POC products do not fit the standard model of regulation.
The MHRA is considering a new regulatory framework to enable the safe development of POC products for supply to patients through clinical trial studies and then on to licensing through a marketing authorisation. The MHRA proposes to use new powers in the Medicines and Medical Devices Act 2021 to amend the law.
The regulatory system is proposed to be based on a Control Site. This will be the primary focus of regulatory controls by MHRA. The Control Site will be a physical site that will be named on the clinical trial or marketing authorisation application. The Control Site would be responsible for overseeing all aspects of the POC manufacturing system including the addition of new manufacturing sites and control of each manufacturing location and their activities.