MHRA publishes new Delivery Plan 2021-2023

The UK MHRA has published its new Delivery Plan 2021-2023.  The plan has one overarching goal which is to deliver for patients and the public.

The new plan is designed to bring together and prioritise the MHRAs existing efforts in one place and to outline a programme that focuses on delivering over the two-year period.

Some of the many deliverables in the plan include the following:

Overhaul the clinical trials system to support innovation and reduce time to approval
  • Encourage a more innovative and pragmatic approach to UK clinical trials via an initiative to facilitate the uptake of novel trial designs and a communication effort to tackle the misperceptions that “traditional” clinical trials are always required for a licence by Q4, 2021/22.
  • Consult on options for changing UK legislation to make conduct of trials generating real-world data easier by Q4, 2021/22.
  • Finalise and promote the Innovative Licensing and Access Pathway (ILAP) Novel Trial Design Tool in partnership with the wider health ecosystem by Q2, 2022/23.
  • Deliver a set of work packages to ensure that AI as a medical device is underpinned by robust evidence to enable safer innovation by Q4, 2022/23.
Develop and deliver future strategy and approach for access to medicines and devices
  • Develop a mechanism to pilot joint clinical trial approval and clinical trial and licensing scientific and compliance advice via Access Consortium by Q4, 2021/22.
  • Further develop the Innovative Licensing and Access Pathway (ILAP) concepts and tools, in collaboration with the National Institute for Health and Care Excellence and the Scottish Medicines Consortium to create a world-class first port of call for medicines development and access by Q3, 2021/22.
  • Support access to generics and biosimilars via more global harmonisation in approval standards; seek membership of International Pharmaceutical Regulators Programme from Q3, 2021/22; take forward discussion of UK Biosimilar guidance in the Access Consortium, a medium-sized coalition of regulatory authorities, from Q3, 2021/22.
  • Develop a mechanism to pilot joint clinical trial approval and clinical trial and licensing scientific and compliance advice via Access Consortium by Q4, 2021/22.
  • Ensure integrated UK regulatory pathways for products that combine medicinal products and medical devices; consultation by Q3, 2022/23.
Establish a new medical devices legislative framework to support safe innovation and ongoing access to products
  • Publish public consultation covering all key aspects of proposed new market access framework by end Q2, 2021/22.
  • Publish a consultation response with finalised policy positions by end Q4, 2021/22.
  • Lay relevant statutory instruments by end Q1, 2022/23.
  • Publish key guidance documents by end Q3, 2022/23 with ongoing engagement with stakeholders over the course of 22/23 to prepare them for the new framework.
Deliver a more responsive safety surveillance and risk management system, for all medical products, to keep patients safe
  • Complete review on new medical devices signals and risk management process, embed risk assessment template and identify opportunities for patient involvement by end Q1, 2021/22.
  • Improve the model of the Devices Expert Advisory Committee and its Expert Advisory Groups by Q3, 2021/22, to ensure greater involvement of independent, scientific, technical, lay and clinical experts in regulatory decision making.
  • Deliver enhanced signal detection process for medicines and medical devices by Q4, 2021/22; service enhancement and international opportunities to defined in Q4, 2021/22 and delivered in 2022/23.
Deliver innovative interventions to ensure the UK has a secure supply chain providing high quality products
  • Pilot voluntary ‘pre-inspection’ checks to fast track new applications for manufacturing licences and piloting the use of consultants as ‘compliance monitors’ in remediation cases by Q3, 2021/22; roll out of automated inspection reports and identify new risk-proportionate approaches with our international partners by Q4, 2021/22; embed file-sharing platforms for remote inspections and visual technology capabilities as a standard part of inspections in 2022/23.
  • Deliver the Great Britain Medicines Verification System, to replace the EU system and enable medicines to be tracked through the supply chain – delivery in partnership with the Department of Health and Social Care and to their timescales when finalised.
  • Deliver a world-leading approach to inspections and enforcement with assurance that products are developed and manufactured to the highest standards and prompt action to reduce criminal threats throughout 2021/22 and 2022/23.

The Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023

MHRA puts delivering for patients at the heart of its Delivery Plan 2021-2023