In this section...
How we support innovation
Continued advances in research and development have lead to the development of new and innovative medicines, medical devices and medical technologies. Examples of this include Advanced Therapy Medicinal Products (ATMPs), nanotechnology, stratified medicines, novel drug/device combinations, and advanced manufacturing. These innovative developments provide new opportunities for improving health provision with respect to medicines and medical devices.
One of the objectives of the MHRA is to support research, ensuring through the application of Better Regulation principles that regulation does not stifle innovation. The Agency is currently engaged in several activities that support innovation both nationally and internationally. This section provides information about this work from across the Agency that supports these activities.
MHRA Innovation Office
For an introduction to the MHRA's Innovation Office please watch our video below.
Scientific and regulatory advice
Scientific and Regulatory advice for the UK
This page provides information about the scientific and regulatory advice offered from the UK.
Go to the page on MHRA scientific and regulatory advice
Scientific and Regulatory advice for the EU
This page provides information about the scientific advice offered from the EU.
Go to the page on EMA scientific advice
Go to the page on EMA ITF
Advanced therapy medicinal products (ATMP)
This section of the site provides advice and guidance on the regulatory arrangements that apply to advanced therapy medicinal products (ATMPs) and answers to frequently asked questions.
Advanced therapy medicinal products
Nanotechnology
Nanotechnology is enabling the creation of a whole range of materials which have novel properties. It is likely to have a wide impact on medical devices, leading to innovative devices. At the nanoscale, changes to the structure of a material can lead to changes in chemical or physical behaviour (ie nanoparticles behave differently from bulk materials). This presents the potential for the development of novel therapies, including smaller implantable devices.
Go to section on Nanotechnology
New Technologies Forum
This section contains information about the Medicines New Technologies Forum and the Medical Device New Technology Forum.
Regulatory Information Service (RIS)
The section includes information about the RIS, which acts as the single main point of contact for marketing authorisation holders of medicines and their representatives.
Regulatory Information Service (RIS) for medicines
Clinical trials
Before a medicine can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective and also that the quality of the product is sufficient. This section contains information on every aspect of the clinical trials process.
Medicines for children
The new regulatory environment for paediatric medicines supports the development of innovative medicines for children. The MHRA engage with a wide range of stakeholders, including professional bodies, research networks and information providers to ensure a clear understanding of the opportunities presented by the new paediatric regulations and provides advice on development of suitable medicines for children, which is free of charge in some circumstances.
MHRA external activities that support innovation for medicinal products
The MHRA has a wide-range of scientific experts that support innovation in the medicines and devices area via their work externally. These include:
Medicines
- Membership on European committees (CHMP, CAT, COMP, PDCO) and CHMP Working Parties (external link).
- Membership of European GDP/GMP Inspectors Working Group.
- Advice given to EMA Innovation Task Force on a wide-range of innovative technologies and products.
- Working within the ICH network.
- Writing regulatory and scientific guidance documents via the ICH and CHMP.
- Presentations on innovative areas at conferences and meetings.
Devices and innovation
Within the Medical Devices Division, there is a dedicated position for horizon scanning of new technologies that could have a potential impact on the development and regulation of medical devices in the future. In addition, there is active engagement and support of a wide range of stakeholders involved in the development of innovative medical devices such as trade associations, professional bodies, technology transfer offices, clinicians, scientists and industry representatives.
Currently, regulatory and scientific advice on all medical devices is provided free of charge. To encourage the early engagement, a web page for new and emerging technologies for medical devices was established. The aim is to support the scientifically sound development of novel technologies and encourage research in innovation in medical devices. Further information provided below.
New and Emerging Technologies for Medical Devices
A key objective of the MHRA is to enable greater access to safe and effective products, and the timely introduction of innovative medical devices and technologies that benefit patients and the public. For more information go to section on new and emerging technologies.
New and emerging technologies for medical devices
MHRA external activities that support innovation in the devices sector
- Membership of European committees such as the Medical Devices Expert group (MDEG), Borderlines and Classification Group, New and Emerging Technologies Working Group (NET).
- Medical devices (external link)
- The Global Harmonisation Task Force (GHTF) - encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade.
- Presentations on the regulation of innovative medical devices and technologies at conferences, seminars and meetings.
