Our Divisions

Communications Division

Communications is a vital part of the MHRA’s work.  If the Agency is to succeed in its mission of safeguarding public health, it must ensure that it communicates in a clear, accurate and timely way with all its stakeholders so that they can make informed choices about medicines and medical devices.

To support this work, the Communications Division was set up in April 2005.  The Division:

• runs an enquiry line to provide information to the patients, public and others who have an interest in our work (contact 020 3080 6000 or email info@mhra.gsi.gov.uk)
• maintains a publicly available Internet site including detailed information on medicines and medical devices
• operates a 24-hour press office to ensure that journalists have access to accurate and timely information
• runs conferences and events to explain our work to stakeholders
• coordinates the Agency’s work with partner organisations, in particular those with whom it needs to work closely to deliver its objectives
• undertakes market research to assess the needs of the Agency’s stakeholders, and recommends actions to address those needs
• manages an internal communications programme to help ensure that MHRA staff have access to the information they need to perform their jobs effectively.

Devices Division

Medical devices range from the most sophisticated diagnostic equipment used in hospitals, to simple bandages and other products sold over the counter to the public. We investigate reports of adverse incidents involving medical devices. 

We receive these from many different sources: 

• the NHS
• private hospitals
• care homes
• manufacturers
• directly from the public.

As a direct result of our investigations, we provide healthcare professionals with relevant advice to improve the safe use of devices. We also work with manufacturers to improve device safety.
This division provides expertise in a number of areas for external stakeholders. These include the scrutiny of proposals from manufacturers for clinical investigations with medical devices in the UK, the negotiation and enforcement of the European Directives and compliance of devices with UK regulations. We also cover notified bodies, registration and interpretational/borderline issues.

Operations and Finance Division

Our Operations and Finance Division is responsible for providing the financial infrastructure to help the Agency achieve its objectives and serve all its customers. 
We help the Agency give good value for money to its customers by providing information, advice and support on financial matters to the management team. 
The Division works with the other parts of the Agency to develop budgets and plans. It then monitors and reports on performance against the budget on a monthly basis, and produces published accounts annually. It manages all financial transactions and controls the Agency's bank accounts.

Human Resources Division

Our Human Resources (HR) Division works in partnership with MHRA managers and staff to provide professional and efficient HR services including the facilitation of a continuous learning and development culture. This is achieved through:

• HR policy - ensuring that all MHRA staff are provided with a HR policy framework that is clear, up to date and accessible.
• HR operations - providing accurate, consistent advice and support regarding HR policies and procedures within reasonable time.
• Organisational development - enabling effective leadership and improving the overall performance of the organisation.
• People development - developing people to be committed and skilled to achieve the Agency’s objectives and enjoy shared success.

Information Management Division

Our Information Management Division has an overall responsibility for Information Management, including the development and implementation of the Agency’s Information Management Strategy, eBusiness, Information Technology, the General Practice Research Database (GPRD), initial processing of licence submissions and the Agency’s delegated authority for Crown copyright.

The Division:

• manages the supplier of its outsourced IT
• manages the Business System Development
• manages the Business System administration
• manages the reference data within databases
• manages the information Fair Trader Scheme associated with Crown copyright delegation
• develops and provides business services to external stakeholders
• develops eBusiness opportunities in line with Government guidance
• provides the Agency input into IT within the EU
• manages a customer focused electronic submission receipt and handling function. 

Inspection, Enforcement and Standards Division

Our Inspection, Enforcement and Standards Division is responsible for ensuring compliance with the standards that apply to the manufacture and supply of medicines on the UK market. This is achieved by licensing and inspecting all UK manufacturers, wholesale dealers and importers of medicines and by inspecting clinical trials and toxicology laboratories. The Division gathers intelligence and investigates suspected illegal advertising, manufacture, importation and sale or supply of medicines for human use; initiating appropriate action which may include legal proceedings. The Division is also responsible for the provision of laboratory testing services to the Agency, classifying whether or not materials and products are medicines, monitoring the importation of unlicensed medicines, ensuring that appropriate action is taken following reports of defective medicines and the management of the British Pharmacopoeia.

Licensing Division

Our Licensing Division has a diverse range of responsibilities. In general it is responsible for assessing and approving applications for marketing authorisations.  These may be new medicinal products (new active substances), new routes of administration or new formulations for existing drugs, generic drugs, parallel import applications, and non-safety variations to existing licences for medicinal products. The Division assesses a wide range of medicinal products, including high tech biotechnology derived product applications, chemical medicinal products, homeopathics and herbals. In addition the Division has responsibility for assessing and granting clinical trial authorisations. 

Our activities span national licensing and European licensing, making a full contribution to the Mutual Recognition system and the Centralised system operated by the European Medicines Agency (EMEA). The Division is also responsible for answering enquiries made by the pharmaceutical industry, the EMEA and other external regulatory agencies via the Service Management function. The Centralised Expert Committee Support team serve as the secretariat for the Agency’s advisory bodies including the Commission on Human Medicines (CHM) and its Expert Advisory Groups (EAGs).

Policy Division

The Policy Division works with the rest of the Agency to ensure alignment between the Agency’s regulatory and public health mandate and the external environment in which the Agency works.

We work with colleagues throughout the Agency to:

• coordinate the Agency’s approach to regulation, ensuring that this responds to developments in thinking about regulatory reform and interest in ensuring a vibrant life sciences sector in the UK
• to coordinate the Agency’s EU and international business
• to coordinate the Agency’s corporate strategy, particularly as this is reflected in the key corporate and planning material that the Agency produces
• to ensure the corporate governance of the Agency.

Policy teams:

• An EU, international and strategy team, responsible for ensuring that the Agency’s interests across the European regulatory networks for medicines and devices are identified and advance, and for negotiating EU proposals for regulation
• A regulatory excellence team, responsible for coordinating the Agency’s regulatory activities, for programme-managing the work of the division (and its contribution into wider Agency business management), and for providing support and challenge to ensure that the Agency's regulation is making the right impact and pursuing objectives that are shared inside and outside the organisation
• A policy, government and corporate team which coordinates policy on a number of specific issues, mostly relating to the interface between product and professional regulation, ensures that the Agency manages its responsibilities to ministers and parliament effectively and manages the corporate business of the Agency.

Vigilance and Risk Management of Medicines (VRMM) Division

The objective of the VRMM organisation is to protect public health by promoting the safe use of marketed medicines, and by supporting this with high quality product information. To this end, we will introduce four organisational attributes. 

• Firstly, we will have proactive and targeted activities which cut across multiple licensed marketed medicines. We will also promote adoption of best practice within these groups. 
• Secondly, we will continue our ongoing vigilance activities to monitor health risks presented by marketed medicines. 
• Thirdly, where public health is considered to be at risk, we will carry out reactive regulatory measures to safeguard it effectively. 
• Fourthly, we will strive to be the primary source of drug safety information, enabling individuals to make informed decisions about the medicines which they use, and will make more medicines accessible to the public. 

VRMM will embrace a number of inter-related functions: pharmacovigilance and pharmacoepidemiology, research and intelligence, therapeutic review and reclassification, a focus on special populations such as children, patient information quality, and advertising standards. These functions will all be proactive in gathering evidence and will focus on public health outcomes.