From factory to bedside: decentralised medicines manufacturing in the UK

This article is part of our Biotech Review of the Year - Issue 13 publication.

The stated aim of the UK’s regulator for medicines, the MHRA, is to make the UK the best country in the world to deploy healthcare innovations safely and for the benefit of patients. 

As a part of this focus on innovation, new legislation was introduced in July 2025 that redefines how innovative medicines can be manufactured and delivered to patients in the UK. The new decentralised manufacturing framework moves medicines manufacturing closer to patients and offers the potential to unlock access to complex and innovative personalised therapies.

Background and drivers

Regulatory frameworks dictate how medicines are manufactured. Conventional pharmaceutical manufacturing relies on a small number of large, centralised facilities producing medicines for global distribution. This model is very efficient for mass production of typical medicines but is unsuitable for:

• personalised therapies that require patient-specific preparation, including many cell and gene therapies;
• ultra-short shelf-life products that cannot survive long transport times; and
• therapies that need to be supplied rapidly in response to an urgent need, such as pandemic vaccines.

Decentralised manufacturing seeks to address existing barriers in the medicines regulatory framework that hinder patient access to these therapies.

Key features of the new framework

Two types of decentralised manufacture

The new regulatory flexibility is introduced through amendments to the UK’s laws governing the regulation of medicines and clinical trials¹. The amendments to these frameworks came into force on 23 July 2025 after a six-month implementation period.

The new provisions introduce a distinction between two models for decentralised manufacture of medicine: point of care (POC); and modular manufacture (MM). This distinction is fundamental to how the new rules operate.

POC medicines are products that are manufactured and supplied at the point where the patient receives care. This will usually mean that the medicine is manufactured in the hospital where the patient is being treated but it can also include home-based manufacture.

MM medicines are products that are manufactured in a mobile, modular unit. These units could be prefabricated manufacturing units that are either self-contained or need to be connected to services at a clinical site.

Designation

The framework limits the new regulatory flexibility by limiting the POC and MM decentralised manufacture designations to only those medicines for which the need for decentralised manufacture can be justified based on clinical benefit. In this context, clinical benefit is assessed broadly and can incorporate elements of improved clinical outcomes, equity and timeliness of access. However, where the benefit is restricted to cost alone, this does not represent a suitable justification for decentralised manufacture.

The legislation provides that:

• POC designation will typically be granted to products with a short shelf-life, such that they “can only be manufactured” at or near the place where the product is to be used or administered; and
• MM designation will be granted to products requiring decentralised, relocatable manufacture that could otherwise be accomplished in a factory, but which is necessitated by “reasons relating to deployment”.

Decentralised manufacture designation can be applied for in respect of products already the subject of a marketing authorisation or products in clinical development. 

Good manufacturing practice (GMP)

Both POC and MM operate through a hub-and-spoke model, whereby a single control site (the hub) holds a manufacturing licence issued by the MHRA. This hub site must meet GMP standards in the way that it supervises and controls the manufacture or assembly of the medicines at the local spoke sites. The hub site is also responsible for the master file associated with the POC medicine or MM medicine. The master file contains a detailed description of the arrangements for manufacture or assembly of the product.

Pharmacovigilance

The legal requirements for pharmacovigilance and the good pharmacovigilance practice (GVP) modules that apply to authorised decentralised manufacture products are the same as those that apply to other authorised medicines. 

For POC and MM medicines, the manufacturing process used is as much a determinant of the product’s quality as the substances within the product. Minor changes or differences in manufacturing steps at local sites can affect the product’s quality and subsequently its safety and efficacy. This fundamental complexity creates specific pharmacovigilance challenges.

For these products, it is essential that products and batches can be traced continuously during clinical use. The local sites must be distinguishable so that emerging safety concerns are rapidly detected and evaluated. Traceability must be fully integrated across the different healthcare settings where the products may be administered.

Opportunities and challenges

This new framework provides a plethora of exciting opportunities, such as:

• The new manufacturing flexibility supports innovative technologies. The framework provides a clear, world-first regulatory pathway for novel manufacturing techniques.
• Therapies can be delivered to patients faster. By reducing reliance on traditional, lengthy supply chains, medicines, especially those with very short shelf-lives, can reach patients more quickly and efficiently.
• Supply chain issues can be mitigated. Manufacturing medicines closer to the patient helps to mitigate issues related to product shelf-life, storage, and logistics associated with centralised production and distribution.
• Clinical trials can be more flexible. The framework provides regulatory clarity for conducting clinical trials with decentralised Investigational Medicinal Products (IMPs), which may boost research and development by allowing for more flexible trial designs and potentially greater patient recruitment and retention.

There are also a number of challenges presented by the new framework, primarily in relation to quality assurance and financial viability.

As set out above, ensuring consistent product quality across a potentially large number of geographically distributed sites may be difficult. This requires robust quality management systems and high levels of automation and standardisation in equipment and processes to minimise variability and new risks emerging.

Although the new framework addresses regulatory barriers that existed previously, other barriers to patients accessing these products remain, primarily in relation to funding these medicines to make them available from the NHS. The high list prices of personalised medicines clash directly with the cost-effectiveness thresholds used by the National Institute for Health and Care Excellence (NICE). This is compounded by the small patient populations and the uncertainty in long-term clinical data, which makes demonstrating cost-effectiveness highly complex for NHS budget holders.

Conclusions

The MHRA’s decentralised manufacturing framework marks a paradigm shift in medicine production. The world-first framework will be monitored closely by international regulators. The proposals for changes to the EU’s pharmaceutical framework include a model similar to the one implemented by the MHRA. In the US, the FDA is also developing a comparable framework. By bringing manufacturing closer to patients, the UK is setting a new standard for agility, innovation, and patient-centric care.

Footnotes

[1] The Human Medicines Regulations 2012 and The Medicines for Human Use (Clinical Trials) Regulations 2004