Your business is considering decentralised manufacturing for a product - what are the steps you need to take?

What is decentralised manufacturing?

The Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004 were amended to provide a regulatory framework for the manufacture of POC and MM products, and this new legislation came into force on 23 July 2025. Through a model of a central "Control Site" and localised "Satellite Sites", products can be manufactured closer to the patient, with the Control Site taking responsibility for and managing the overall manufacturing process.  

The value and potential of this new framework should not be understated. I recently attended NSF's annual Pharma Biotech Conference, which included a session on decentralised manufacturing. Dr Peter Gough, Vice president and Principal Consultant at NSF Life Sciences, and a leading provider of training and standards in life sciences regulatory matters, said: “The implementation of this new DM process represents a significant milestone for the UK and the wider world. The MHRA has led the development of this new process, working with partner regulatory authorities in ICMRA, and will now lead the world in its practical application."  

What is the role of the Control Site?

The Control Site will:

• be the only location named on clinical trial authorisation (CTA) or marketing authorisation (MA) applications
• prepare, hold and update the Decentralised Manufacture Master File (DMMF) for the relevant product
• hold the manufacture's licence, which will have a POC or MM authorisation (as appropriate) to permit the manufacture or assembly of the relevant product using DM processes.

Can any product be manufactured using DM processes?

Your business will need to apply to the MHRA for a DM designation. The MHRA will decide if DM is justified for either POC or MM with reference to certain criteria, which can be found here. The MHRA encourages applicants to apply for designation as soon as it is determined that the relevant criterion is met. Your business will need confirmation of a DM designation before making an application for a new MA or CTA, or applying to amend an existing one, or beginning the manufacture of an unlicensed medicine.

Your business has an existing manufacturer's licence - how can this be varied?

If your business holds a manufacturer's licence for a product and you want to use DM processes, you will need to apply to vary the scope of your licence to include the manufacture of the POC or MM product (and name either a POC or MM Control Site).  

What are the contractual considerations?

DM processes will in many cases involve a number of different companies, likely outside of a business's group structure, and potentially working together across a large area. This complex working relationship will need to be supported by a robust contractual framework and clear policies and processes.

Firstly, as a general point, DM processes involve a lot of moving parts and, in the case of many patients, treatment is likely to be time sensitive and scheduled to work around other treatment. It's important to have the basics in good order and ensure that your agreements with parties are clear on exactly what needs to be done, by who and by when.  

There are also some specific contractual considerations, including:

• The Control Site will be responsible for overseeing all aspects of the manufacturing process. If your business is the owner/operator of the Control Site, it is therefore important that you include sufficient rights and obligations in your agreements with the Satellite Sites to ensure you can fulfil this responsibility, including:
  • rights to access quality systems including deviations and change controls
  • an obligation to notify you of suspected adverse reactions
  • an obligation to notify you of any proposed material changes to processes or the facilities
• In turn, there are certain things that Satellite Sites will want to see in their agreements with the Control Site:
  • an assumption of responsibility by the Control Site for its regulatory obligations and duties
  • an obligation for the Control Site to inform them of any routine inspections of its site and the outcome of those inspections
  • a commitment to agreed timescales and delivery arrangements
• There will of course be exchange of know-how and formulations between different parties, including outside of a group structure. Ensure that your agreements contain robust intellectual property protections, but do not prevent quick and effective DM processes.
• Particularly with new relationships, it is important that your agreements sufficiently protect your interests, as well as allowing for adaptation or exit if things go wrong or do not work out as expected. Key clauses will include appropriate termination rights, suitable force majeure clauses, a clear process in the event of disputes, and obligations around communication and review.

What other practical steps do I need to take?

• Consider and implement a plan for robust traceability. As the MHRA comments in its guidance on Good Pharmacovigilance Practices, there is likely to be slight changes and deviations to manufacturing processes and also variations in infrastructure for data recording and linkage across the different individual sites. Because of this, it important that there is a robust system in place to ensure product and batch traceability throughout the product's life cycle, so that personalised products can reach the right patient and safety concerns can be quickly detected and addressed. 
• Don't ignore packaging requirements. The MHRA has clarified in its guidance that the legislative labelling requirements for each type of medicinal product must still be complied with, with the exception of POC products where there is a requirement for immediate administration and that administration takes place after its manufacture and no product is retained.
• Be aware of any new guidance or changes in approach. DM processes are novel and it is likely that guidance will adapt over the coming months and years as businesses begin implementation. The MHRA has published guidance on various aspects of DM on a dedicated hub, so keep an eye on that page.
• Consider the impact on sustainability. DM processes have the potential to be more sustainable than traditional manufacturing processes as these are undertaken locally, but there is also a risk that more individual sites could increase your business's carbon footprint and waste. If your business or a part of your supply chain is considering DM processes, it is important to consider the impact on your business's sustainability goals and strategy.  

The theme of our PING Conference this year was "Sustainability - What must pharma do now?" Following the Conference, we have been hosting online roundtables for a deeper discussion on certain topics. The subject of our final roundtable on 1 December is how to work with your supply chain to achieve better sustainability outcomes. Please get in touch if you would like to join the session. 

Will other countries follow the UK?

At the time of writing, only the UK has introduced a DM framework, and this requires that applicants have a legal presence in the UK to apply for designation. However, other territories are looking to implement DM frameworks:

• The EU's proposed new Directive to revise its medicines legislative framework, which will repeal Directives 2001/83/EC and 2009/35/EC, includes a model similar to the UK's framework.
• The USA has the Food and Drug Administration’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to develop a regulatory framework for advanced manufacturing technologies, with one area of focus being DM. 

Regulators around the world will be closely watching the UK's implementation of DM processes, and thinking about how they can take a similar approach to benefit patients.

For more information or advice, please contact Emily Dyer in our Pharmaceuticals and Life Sciences team.