MHRA launches Innovation Accelerator service

The UK MHRA has launched an Innovation Accelerator service. The service will help provide innovators access to MHRA scientific expertise and regulatory guidance, helping developers of innovative products (medicines, medical devices (including software) and blood components for transfusion) connect more dynamically with an enhanced advice and signposting service.

The Innovation Accelerator functions bring together the following:

  • Innovation Office
  • The Regulatory Advice Service for Regenerative Medicines (RASRM),
  • Regulatory Science and horizon scanning.

It also supports the delivery of the Innovative Licensing and Access Pathway (ILAP).

This RASRM service offers research and development professionals across academia, industry and the NHS (including clinicians) a single point of access to free, joined-up regulatory information, advice and guidance from:

Here, you can find case studies demonstrating how MHRA has helped a number of companies navigate the regulatory processes for innovative new medicines and medical devices.

Below is an example of one such case study:

Horizon Scanning Case Study: Point of Care manufacture

Technology is enabling the creation of new medicinal product types with features such as a very short shelf-life ranging from30 seconds to a few hours, necessitating manufacturing at the point of care (POC), as well as other highly personalised products. The types of products with these features include:

  • Advanced Therapy Medicinal Products (ATMPs),
  • blood products,
  • 3D-printed small molecules and
  • some medical gases.

Through horizon scanning and examining trends in information obtained from requests for regulatory and scientific advice, borderline classification opinions and the presence of some products in clinical trials MHRA identified that there are a wide range of medicinal products in development that will require POC manufacture.

The issue with these products is that they do not fit the current ‘standard model’ of manufacture and supply, which typically features centralised manufacture of large batches of stable products at a few manufacturing sites.

The current regulatory framework of centralised manufacture of medicinal products

The current regulatory framework is geared towards the centralised manufacture of medicinal products so that each product (or product type) is manufactured at a relatively small number of sites at large scale. As the products normally have a long shelf-life. they are distributed globally from these sites to a mass market. Current regulations require each manufacturing site to be named on the Marketing Authorisation and to inspect and authorise each of those sites.

The need for change that horizon scanning helped to identify

Horizon scanning identified a need for a new regulatory framework to enable the development of POC manufacture and supply in the UK.

This framework will accommodate the needs of medicines products manufacture at POC but will also provide control measures equivalent to those currently in place for medicinal products manufactured in factory-based locations. This will ensure that POC products have the appropriate quality, safety, and efficacy attributes.

MHRA action taken thus far
  • Following internal discussions, the MHRA engaged extensively with stakeholders involved in the development, manufacture, testing, clinical trials and licensing of POC products in the UK.
  • In 2020, workshops were organised to explore the technologies and products that are applicable to POC manufacture and the control measures that would need to be established to support their safe development.
  • In March 2021, at a stakeholder engagement event the MHRA presented a high-level view of a proposed regulatory framework for POC manufacture, which is centred on the concept of a Control site.
  • This Control site would be named on clinical trial and marketing authorisation applications and would oversee all aspects of the POC manufacturing system including the individual manufacturing locations and their activities.
  • The proposed regulatory framework is based on and links into current regulatory systems for medicines approval, clinical trials, evaluation of regulatory compliance at manufacturing sites and safety monitoring.
  • Following discussions and feedback from attendees at the above event, the MHRA prepared a consultation document and a public consultation was undertaken.
  • Responses were highly positive and there was also support for the framework to apply across the full range of manufacturing scenarios, from modular manufacture to home-based manufacture
Outcomes

Through horizon scanning and review of the regulatory and scientific advice signals received, the need to amend The Human Medicine Regulations 2012 and The Medicines for Human Use (Clinical Trials) Regulations 2004 was identified in order to create a new framework to enable the supply and increase the availability of innovative new medicinal products made at POC, to patients.

  • Both of the above regulations are in the process of being amended.
  • New Statutory Instruments are due to be laid in Parliament later in 2022.
  • At that time, guidance documents will be developed in consultation with stakeholders

The UK will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care. MHRA is in discussion with a range of international regulators to support the development of a similar framework in those territories to allow patients to access POC products.

Source (MHRA): Innovation Accelerator, MHRA innovation case studies, Horizon Scanning Case Study: Point of Care manufacture