UK MHRA's Guidance: UK’s Decentralised Manufacture Framework: A Holistic Overview
- Sharan Murugan
- Jun 13
- 3 min read
In the evolving landscape of pharmaceutical manufacturing, Decentralised Manufacture has emerged as a pivotal approach, especially in enhancing flexibility and patient access. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a series of guidance documents outlining various regulatory aspects of decentralised manufacturing.
The designation step forms the regulatory foundation of decentralised manufacture. Before any product can be manufactured and supplied under this model, the licensing authority must design the site.
Key highlights include:
The manufacturer must submit a Designation Request Form before implementation.
The site must meet the requirements of Good Manufacturing Practice (GMP).
This process ensures regulatory oversight while allowing manufacturing flexibility closer to the point of care (e.g., hospital or pharmacy settings).
This step is essential to ensure patient safety and maintain quality standards in a decentralised setup.
Once a site is designated, obtaining a Marketing Authorisation (MA) is the next critical phase. Under the decentralised model, the MA application must clearly outline:
The product-specific decentralised manufacturing process.
The proposed supply chain and oversight mechanisms.
Evidence demonstrating compliance with GMP and pharmacovigilance standards.
The MA holder retains full responsibility for product quality, efficacy, and safety, regardless of decentralisation. This ensures consistency and traceability throughout the supply chain.
Pharmacovigilance plays a crucial role in monitoring the safety profile of medicines. The UK guidance emphasizes that decentralised manufacture must not compromise adverse event reporting and risk management.
Key provisions include:
The MA holder must implement a robust pharmacovigilance system.
All stakeholders, including local manufacturing units, should be integrated into a centralised reporting system.
There should be clear documentation and traceability of pharmacovigilance responsibilities at every level.
This integrated approach safeguards patient welfare while enabling operational decentralisation.
Labelling in a decentralised manufacturing context introduces complexities that must be carefully managed. The MHRA outlines specific criteria to ensure accurate, consistent, and compliant labelling at all decentralised sites.
Core guidelines include:
All labels must comply with the Human Medicines Regulations 2012.
Adequate measures must be in place to ensure version control and real-time updates.
The decentralised site must be authorised to apply labels, and any label application should be traceable and auditable.
This framework ensures that product integrity and regulatory compliance are preserved, regardless of where the labelling occurs.
Guidance: Clinical Trial Authorisation and Good Clinical Practice (GCP)
Decentralised manufacture is also applicable in the clinical trial context, especially with increasing interest in decentralised clinical trials (DCTs). The UK guidance ensures that any manufacturing related to clinical trials complies with both CTA requirements and GCP principles.
Notable directives include:
A separate application or notification may be required depending on the extent of decentralised manufacture.
The Qualified Person (QP) must oversee the release of the investigational medicinal product (IMP).
All activities should align with clinical trial protocols, maintaining participant safety and data integrity.
This guidance bridges the gap between innovation and regulatory rigour in clinical research.
Decentralised manufacture introduces variability in the location of production activities, making strict adherence to GMP more critical than ever. The MHRA’s guidance outlines specific responsibilities for GMP compliance in this context.
Core expectations include:
All decentralised manufacturing activities must meet EU GMP principles, particularly those outlined in EudraLex Volume 4.
There must be a clear Quality Management System (QMS) connecting the MA holder and decentralised sites.
Activities like reconstitution, packaging, or labelling must be standardised and validated to prevent variability or errors.
The Qualified Person (QP) retains ultimate responsibility for batch certification.
This ensures decentralised manufacture does not compromise product quality or patient safety.
Decentralised manufacture represents a transformative step toward agile, patient-centric pharmaceutical production. By adhering to the UK’s clear regulatory framework—from designation and MA to pharmacovigilance and labelling—stakeholders can harness the benefits of decentralisation without compromising on quality or safety.
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