Terms of reference

These are the published terms of reference for the Medicines and Healthcare products Regulatory Agency.

The Board

The Board is primarily responsible for advising on the strategic development of the agency and ensuring that targets set out in our business plan and endorsed by ministers are met.

The responsibilities of the board are set out in the MHRA framework document (PDF, 362KB, 36 pages)

The Board is responsible for monitoring the implementation of ministers’ objectives for the strategic direction of the agency, taking into account the perspective(s) of its stakeholders, and advising ministers and the agency accordingly.

In particular this includes the content of the agency’s annual report including:

  • corporate governance and financial management
  • business strategy and corporate objectives
  • five-year corporate plan (link needed) and annual business plan (link needed)
  • key financial and performance targets
  • culture and values
  • internal and external communications management and quality

The Board monitors the effective, efficient and economic delivery of the agency’s objectives and ensures that the agency fulfils its core objectives and complies with all statutory and administrative requirements for the use of agency funds and the maintenance of the highest standards of corporate governance and public accountability.

The Board, as a whole, does not exercise any line management or executive functions, nor does it have a legal or constitutional role or any liability in respect of decisions of the executive. It does not determine the details of regulatory policy, nor does it have any involvement in any regulatory decisions affecting medicines or medical devices. These are the responsibility of the chief executive, working through corporate executive team (CET) directors and their staff, and of the expert advisory committees.

The Board use their experience and expertise and meet these responsibilities by:

  • meeting on a regular basis
  • attending sub-committees eg Audit and Risk Assurance Committe
  • considering strategy papers from the CET and other agency staff as necessary
  • attending occasional agency events including all-staff meetings, agency annual lectures and informal briefing meeting with executive staff where necessary

Membership

The Board will consist of not more than 12 individuals and will be chaired by the agency chairman. Non-executive members will be appointed by the Secretary of State following open competition and do not represent any specific customer, sectoral or stakeholder interests. Since 18 September 2015, when the Board adopted a unitary structure, the Chief Executive and the Chief Operating Officer now serve as executive members of the Board. The policy director, communications director and a member of the Department of Health’s Legal Services usually attend to inform the Board on the agency’s business. Other executive directors will attend when necessary.

Frequency of meetings

The Board will normally meet formally 11 times a year; this includes a joint Board/ Corporate Executive Team away day.

Board reporting

The directorate will provide the secretariat for the Board. Minutes of the Board meetings will be provided to the CET for information and consideration. Redacted minutes will be made available to staff and on the agency website.

Corporate executive team

The corporate executive team (CET) is the highest executive decision-making body of the agency.

The CET’s primary responsibilities are to ensure that:

  • the strategic direction of the agency is developed in co-ordination with the agency board
  • the strategic direction, as set out in the 5-year corporate plan, is implemented and delivered through the business plan
  • the agency’s performance targets are met the agency follows the principles of good governance, including:
  • risk management and assurance
  • financial management and assurance
  • information management and assurance
  • health and safety assurance
  • management of corporate ethics and conflicts of interest; and
  • quality management and assurance
  • oversight of the activities of the 3 centres within the agency

The CET will meet these responsibilities by:

  • developing the 5-year corporate plan, setting out the strategic focus for the agency in the next period, for annual review and agreement by the AB
  • agreeing, and overseeing the implementation of, the key strategies that cascade from the corporate plan, including on:
    • finance
    • workforce planning
    • communications
    • information technology
    • regulatory and standards
    • EU and international
    • Clinical Practice Research Datalink (CPRD)
    • innovation
  • agreeing, and overseeing the implementation of, an annual business plan, aligned with the 5-year corporate plan
  • monitoring of performance against the principles of good governance (as above)
  • monitoring the performance and activities of the regulatory, National Institute for Biological Standards and Control (NIBSC) and CPRD centres by way of quarterly governance reports, which will include an assessment against key performance indicators – agreed by CET - for the NIBSC and CPRD centres
  • providing a corporate view on specific issues that are brought to CET by directors
  • agreeing all papers that are submitted by the executive to the AB
  • monitoring of, and reporting to the agency board on, performance against the corporate plan, business plan and operations of the agency

The CET will devolve certain areas of its business to sub-groups, each chaired by a designated director. The CET may also initiate time-limited programmes of work, each led by a designated director. Each of these groups will have their own terms of reference, agreed by the CET.

Frequency of meetings

The CET will meet informally on a weekly basis to share intelligence on emerging issues and to highlight key events in the week ahead. These meetings do not formally consider strategy or governance matters.

The formal responsibilities of the CET will be carried out through a single monthly meeting.

The CET will also meet once per month for a CET mini away day to explore emerging strategic issues. Full away days will also be held.

CET reporting arrangements

Minutes of formal CET meetings will be provided to the agency board.

Quarterly governance reports from the following will be provided to the CET by:

  • NIBSC senior management team, CPRD executive committee and the MHRA regulatory group (RG), covering the activities and performance of each of the 3 centres
  • CET sub-groups and time-limited programmes of work

Minutes of the MHRA RG will be submitted to the CET for information together with the current issues register.

The directors of NIBSC and CPRD will make monthly reports to the CET on the activities of the senior management team and executive committee respectively.

Membership

The CET is chaired by the chief executive and has as members the directors of the corporate divisions, operating divisions and NIBSC and CPRD centres. A representative from the Department of Health Legal Services shall also attend the CET.

The membership is:

  • the chief executive as chair
  • the directors of: devices division, communications division, information management division, policy division, finance and procurement, human resources, licensing division, inspection, standards and enforcement, vigilance and risk management of medicines, the NIBSC and CPRD

Alternates will be required where full members are unavailable.

Conflicts of interest

Members and alternates will comply with established procedures for MHRA: dealing with conflicts of interest (PDF, 192KB, 12 pages) .

Transparency

The agency’s guiding principle is full transparency unless non-disclosure is justified on the basis of established freedom of information exemptions. Final agreed minutes of CET meetings will be published each month following any necessary redactions.