Guidance

Innovation Accelerator

Updated 17 January 2023

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This publication is available at https://www.gov.uk/government/publications/innovation-accelerator/innovation-accelerator

How to get in touch

Innovation Office

The Innovation Office is open to queries from those developing;

It provides accessible regulatory information, advice and guidance to organisations of all backgrounds and sizes based in the UK or internationally (industry, academics and patient groups).

We will triage and assess your request based on your information and needs, providing you with advice and guidance that will help you navigate the regulatory framework and understand the important next steps.

This is a free service.

More information and enquiry form.

Regulatory Advice Service for Regenerative Medicines

This advice 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:

Please use the Innovation Office enquiry form and state this is a request to the Regulatory Advice Service for Regenerative Medicines.

Get scientific advice from MHRA

You can ask for scientific advice from the MHRA at any stage of the development of your medicine. You can request a broader scope scientific advice or request a joint meeting with MHRA and National Institute for Health and Care Excellence (NICE).

These activities are fee-for-service.

Find out more and request a meeting.

Innovative Licensing and Access Pathway

The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to innovative medicines. These medicines include new chemical entities, biological medicines, new indications and repurposed medicines.

The ILAP is open to both commercial and non-commercial developers of medicines (UK based and/or global) and provides opportunities for enhanced regulatory and Health Technology Assessment agency input.

If you have any questions about this pathway please email innovationpassport@mhra.gov.uk.

Find out more about ILAP.

Additional information and training

MHRA innovation case studies

The MHRA has co-developed case studies demonstrating how the regulator has helped a number of companies and organisations navigate the regulatory processes for innovative healthcare products.

Horizon scanning

Horizon scanning aims to future-proof the work of the MHRA by systematic detection and assessment of early signs of potentially important regulatory developments, to ensure we remain a regulator capable of supporting safe innovation with respect to healthcare products: it helps to make us better at what we do.

Horizon scanning supports the pathway of innovative products from idea to adoption by identifying and seeking to overcome barriers, including, where needed, making changes through Regulatory Science: See the following examples:

If you have any suggestions for horizon scanning signals, please email innovation.accelerator@mhra.gov.uk.

Regulatory Science

The MHRA is keen to identify future priorities for Regulatory Science in the UK and to explore how advances in Regulatory Science can enable efficient and effective regulation of current and emerging healthcare products.

Regulatory Science at MHRA, whilst maintaining the confidentiality of information received, means the assessment of signals to develop new regulatory tools and systems to enable improved regulatory decision-making throughout the lifecycle of healthcare products.

If you have any suggestions for area of focus of regulatory change needs or topics for which guidelines are lacking or outdated, please email innovation.accelerator@mhra.gov.uk.

Training opportunities and workshops

If you have a specific training need, please email us at innovation.accelerator@mhra.gov.uk.

We will consider requests for training, subject to demand.

Future training and workshop opportunities will be listed here.

See all upcoming MHRA conferences and events.

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