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One of the key objectives of the MHRA is to support greater access to safe and effective medicinal products and medical devices. The timely introduction of innovative products benefits both patients and the public. This section provides information about the MHRA Innovation Office and highlights how you can get scientific and regulatory advice to support the development of innovational products.
The MHRA Innovation Office
The MHRA Innovation Office helps organisations that are developing innovative medicines, medical devices or using novel manufacturing processes to navigate the regulatory processes in order to be able to progress their products or technologies. Examples of innovative products include Advanced Therapy Medicinal Products (ATMPs), nanotechnology, stratified medicines, novel drug/device combinations, and advanced manufacturing.
Innovation case study: AstraZeneca
SynopsisUnderstanding regulatory requirements at the start of an innovative site development is important when considering the design, cost and timelines of the project. Find out how the MHRA’s supportive and collaborative approach helped AstraZeneca meet these challenges and successfully complete its £120m manufacturing facility in Macclesfield. Read the full innovation case study (298Kb).
Regulatory queries on regenerative medicines (one stop shop)
From 13 October 2014, the MHRA’s Innovation Office will be the portal for all regulatory queries concerning regenerative medicines. A “one stop shop” service provides a single point of access from the four regulators in the field, the Human Tissue Authority (HTA), the Human Fertilisation and Embryology Authority (HFEA), Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA), who will provide a co-ordinated single response service for free regulatory advice.
The term “regenerative medicine” is used to refer to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices.
Any query relating to the regulation of regenerative medicines, including Advanced Therapeutic Medicinal Products (ATMPs) can be submitted to the MHRA’s Innovation Office and will be answered by the relevant experts from the four regulatory bodies.
Individuals or companies who have regulatory questions concerning regenerative medicines and who are unsure which agency to direct their inquiry to, or have a query that impacts several regulators, should use the Innovation Office enquiry form.
If you are unsure on the status of your product, applicants can contact the MHRA for a classification of a potential ATMP using our ATMP advice form.
Contact the MHRA Innovation Office
If you are a pharmaceutical researcher, developer, manufacturer, etc. and you have a question about an innovative medicine, device or novel manufacturing process, contact the MHRA Innovation Office using one of the routes below.
After contacting the office you will receive a response within 20 working days. Depending on the nature of the query, your response will consist of either a simple answer or a recommended course of action, which may involve regulatory or scientific advice.
The Innovation Office has put some information together which you are encouraged to read before you submit a query to the office.
Regulatory incentives and legal flexibilities
Find out more about regulatory schemes that support drug development, licensing and patient access to innovative therapies:
Introduction to the MHRA's Innovation Office
For an introduction to the MHRA's Innovation Office please watch our video below.
Scientific and regulatory advice
The MHRA offers regulatory and scientific advice. For medicines, we currently carry out over 250 scientific advice meetings a year. Joint meetings can be held with the National Institute for Health and Care Excellence (NICE) to consider health technology assessment issues at the same time.
Scientific advice from the EU
The European Medicines Agency (EMA) offers a comprehensive scientific advice service, available to provide assistance during the initial development of a medicine and during the post-authorisation phase. The advice is provided by the EMA’s Committee for Medicinal Products for Human Use (CHMP) (external link), based on recommendations of the Scientific Advice Working Party (SAWP) (external link).
Further advice on accessing scientific advice from the EMA:
Scientific advice and protocol assistance (external link)
Scientific advice from the UK
The MHRA offers a comprehensive scientific advice service which can assist companies in making decisions about a range of regulatory issues. Scientific advice can be requested at any stage of the initial development of a medicine and also during the pre-submission period.
Information on how to apply for scientific advice:
What the MHRA is doing to support innovation
- Membership on European committees (Commission on Human Medicinal Products (CHMP), CAT, COMP, PDCO) and CHMP Working Parties (external link)
- Membership of European Good Distribution Practice (GDP)/Good Manufacturing Practice (GMP) Inspectors Working Group
- Advice given to European Medicines Agency (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
- Membership of European GDP/GMP Inspectors Working Group
- Membership of European committees such as the Medical Devices Expert group (MDEG), Borderlines and Classification Group, New and Emerging Technologies Working Group (NET)
- The Global Harmonisation Task Force (GHTF) (external link) encourages convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade
Regulation of specific innovative products
This section of the site provides advice and guidance on the regulatory arrangements that apply to Advanced Therapy Medicinal Products (ATMPs) and contains answers to frequently asked questions.
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 innovation. 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.
Medicines for children
The new regulatory environment for paediatric medicines supports the development of innovative medicines for children. The MHRA engages 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.
This section of the website contains information about new and emerging technologies for medical devices.