2024-10-23 9:53:17
In 2023, the Government announced that it would introduce a series of new measures to make it faster and easier to gain approval and to run clinical trials in the UK. It said that the clinical trials application processes in the UK would be “more proportionate, streamlined and flexible without compromising on safety, helping to cement the UK as an attractive destination for trials, including global “multi-site” trials. For example, the integration of the regulatory and ethics reviews of clinical trial applications, which in pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days, will be embedded into the new regulation.”
The Government has now published the draft Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024. What follows is an extract from the Explanatory Note to the draft Regulations: there is no date yet for bringing the Regulations into force.
“These Regulations make provision for medicinal products that are manufactured in a modular unit, to enable deployment from that site. This is known as modular manufacture (“MM”) and the products are referred to as “MM medicinal products”. The Regulations also make provision in relation to the manufacture and supply of medicines that are innovative and have particular characteristics such as a very short shelf life, or that are highly personalised to the recipient. These characteristics mean that the medicines have to be manufactured very close to the place where they are administered. The type of manufacture is known as point of care (“POC”) and the products are referred to in the Regulations as “POC medicinal products”.
POC medicinal products cannot be manufactured in advance in conventional, factory-based sites and distributed to supply sites from there. They have to be manufactured in small amounts in close proximity to the patient at sites that are likely to be healthcare facilities such as pharmacies, operating theatres and clinics. The number of sites at which a product is manufactured may be comparatively high, and sites may be added or removed depending on circumstances. The regulatory framework that currently applies to medicines manufacturing, whereby each site is named on the licence and individually inspected and authorised, requires adjustment to allow for this new manufacturing structure. These Regulations make the necessary amendments to the HMRs so that the manufacture of POC medicinal products is regulated by way of an authorisation and a master file that relates to the product. Similarly, the current regulatory framework is not appropriate for manufacture in units that may be relocated, so the Regulations make equivalent amendments, where necessary, in relation to modular manufacture.”