The Medicines and Healthcare products Regulatory Agency (MHRA) has recently broadcast that the UK is set to be the first nation to implement a bespoke framework covering the legalities surrounding production of innovative goods made when an individual gets treatment.

As a result, highly individualised medications and novel drugs with extremely limited shelf lives can be produced simply and close to a hospital environment or ambulance. This means they will reach people in need much faster.

“new regulations are being created to revise the existing Human Medicines and Clinical Trials laws“

The purpose is to guarantee that there are no legal obstacles to innovative production of pharmaceutical products, and that the items produced in this way are up to the same standards of quality, safety, and efficacy as those made using more traditional manufacturing methods.

This comes after the MHRA had a public discussion with points made by a variety of people and organisations from across the globe. There was a distinct emphasised how crucial it is to develop a regulatory framework for essential and diverse Point of Care products.

Later in 2023, new regulations are being created to revise the existing Human Medicines and Clinical Trials laws. These must be introduced to Parliament in order to execute the application of this framework.

Alongside stakeholders, the MHRA will start creating guidelines to go along with the framework, which are to be released as soon as possible.

In order to assist the production of comparable regulatory systems, efforts have already begun on creating a coordinated approach with other authorities in the UK and abroad.

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