The government is planning a new regulatory framework to cover products such as personalised medicines that are manufactured at the point of care,
In a consultation launched last week, the government says that technology is enabling the creation of new types of medicinal product that have features such as very short shelf lives and which may be highly personalised, requiring them to be manufactured and supplied at the point of care (POC).
Medicines regulation is currently geared towards products that typically have a shelf life measured in years and which are manufactured at large scale in a relatively small number of factory-based sites. POC products do not fit this ‘standard model’ of regulation, since manufacture may intended for a specific individual, be done in a hospital and supplied immediately to a patient.
The proposed regulatory framework is based on, and links into current regulatory systems for medicines approvals, clinical trials, evaluation of regulatory compliance at manufacturing sites and safety monitoring.
The aim is to support increased manufacture of POC products whilst ensuring they attain the same assurance of safety, quality and efficacy currently in place for more conventional medicinal products, says the government.
The MHRA has developed a proposal for such a POC framework which it believes will enable the growth of an emergent pharmaceutical manufacturing and supply sector.
The government is proposing to use powers under the Medicines and Medical Devices Act 2021 to amend the regulatory framework for manufacture of medicinal products. The framework will apply across the UK.
The consultation runs until 23 September.