Our governance

The main decision-making, executive and managerial bodies at Medicines and Healthcare products Regulatory Agency.

Corporate governance

We’re governed by a Board, which is advised by the Corporate Executive Team (CET).

The Board

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

The Board does not have any involvement in any regulatory decisions affecting medicines or medical devices. These are the responsibility of the chief executive, working through the corporate executive team, and of the expert advisory committees.

Full details of the Board’s responsibilities can be found in our Board Operating Framework (PDF, 189KB, 15 pages).

Members

The Board is chaired by MHRA’s chairman, and consists of 9 non-executive directors (NEDs) and 2 executive members (chief executive and chief Operating Officer).

  • Sir Michael Rawlins GBE, Kt (chair), Emeritus Professor, University of Newcastle upon Tyne
  • Dr June Raine CBE, Chief Executive, MHRA
  • Mr Jon Fundrey ,Chief Operating Officer and Director of Finance, MHRA
  • Dr Barbara Bannister MBE, honorary consultant at the Royal Free Hospital and advisor on military medicine to the Ministry of Defence
  • Amanda Calvert, Non-Executive Director of The Guinness Partnership Limited a provider of social housing and care services and a member of the Advisory Board of the Cambridge Judge Business School
  • Professor Bruce Campbell, consultant vascular surgeon at the Royal Devon and Exeter Hospital and Honorary Professor at the University of Exeter Medical School
  • Stephen Lightfoot, Deputy Chair of Sussex Community NHS Trust
  • Anne-Toni Rodgers, Pharmacologist and Director of a management consultancy
  • Professor David Webb, (Deputy Chair of the Board) Christison Chair of Therapeutics and Clinical Pharmacology at the University of Edinburgh
  • Michael Whitehouse OBE, Accountant and auditor, and non-executive director with other bodies
  • NED position currently vacant
  • NED position currently vacant

Board members’ declarations of interest

Board members' list of declarations (PDF, 103KB, 6 pages)

Minutes

Agency Board minutes (public session): 16 December 2019 (PDF, 169KB, 6 pages)

Agency Board minutes (public session): 16 September 2019 (PDF, 209KB, 7 pages)

Agency Board minutes: 22 July 2019 (PDF, 182KB, 7 pages)

Agency Board minutes: 15 April 2019 (PDF, 205KB, 7 pages)

Agency Board minutes: 17 December 2018 (PDF, 169KB, 8 pages)

Agency Board minutes: 19 November 2018 (PDF, 211KB, 9 pages)

Agency board agenda: 15 April 2019 (PDF, 118KB, 1 page)

Agency Board minutes: 22 October 2018 (PDF, 180KB, 9 pages)

Agency Board minutes: 16 July 2018 (PDF, 193KB, 8 pages)

Agency Board minutes: 25 June 2018 (PDF, 171KB, 7 pages)

Agency Board minutes: 21 May 2018 (PDF, 160KB, 8 pages)

Agency Board minutes: 23 April 2018 (PDF, 161KB, 9 pages)

Agency Board minutes: 26 March 2018 (PDF, 171KB, 8 pages)

Agency Board minutes: 26 February 2018 (PDF, 159KB, 8 pages)

Agency Board Minutes: 15 December 2017 (PDF, 183KB, 7 pages)

Agency Board Minutes: 20 October 2017 (PDF, 184KB, 9 pages)

Board Minutes: 23 June 2017 (PDF, 239KB, 8 pages)

Board Minutes: 20 May 2017 (PDF, 231KB, 7 pages)

Minutes Public Board 24 April 2017 (PDF, 408KB, 7 pages)

Board Minutes: 17 March 2017 (PDF, 236KB, 8 pages)

Board Minutes: 17 February 2017 (PDF, 231KB, 8 pages)

Information note for MHRA’s Board meeting (in public session) - 24 April 2017 (PDF, 314KB, 1 page)

Agency Board minutes: September 2014 (PDF, 235KB, 8 pages)

Agency Board minutes: 15 July 2016 (PDF, 217KB, 6 pages)

Information note - 12 December 2016 (PDF, 309KB, 1 page)

Agency Board minutes: July 2014 (PDF, 223KB, 7 pages)

Agency Board agenda: 12 September 2016, public session (PDF, 120KB, 1 page)

Information note for MHRA’s 12 September board meeting (in public session) (PDF, 309KB, 1 page)

Agency Board minutes 14 March 2016 (PDF, 221KB, 6 pages)

Agency Board minutes: 9 May 2016 (PDF, 238KB, 9 pages)

Agency Board (part two) minutes 11 April 2016 (PDF, 203KB, 5 pages)

Agency Board minutes: 12 February 2016 (PDF, 177KB, 5 pages)

Agency Board minutes (part two) 12 February 2016 (PDF, 193KB, 3 pages)

Agency Board agenda: 11 April 2016, public session (PDF, 118KB, 1 page)

Agency Board minutes: 9 December 2015 (PDF, 40.1KB, 5 pages)

MHRA Board meeting 11 April 2016 (PDF, 118KB, 1 page)

Agency Board minutes: 20 November 2015 (PDF, 142KB, 6 pages)

Agency Board minutes: 16 October 2015 (PDF, 217KB, 6 pages)

Agency Board minutes: 18 September 2015 (PDF, 52.6KB, 7 pages)

Agency Board minutes: 15 May 2015 (PDF, 212KB, 5 pages)

Agency Board minutes: 18 February 2015 (PDF, 218KB, 6 pages)

Agency Board minutes: 7 November 2014 (PDF, 223KB, 7 pages)

CET minutes: 14 July 2015 (PDF, 286KB, 7 pages)

Agency Board agenda: 12 February 2016, public session (PDF, 111KB, 1 page)

Agency Board minutes: 16 December 2014 (PDF, 212KB, 5 pages)

Agency Board minutes: 7 November 2014 (PDF, 223KB, 7 pages)

Agency Board minutes: September 2014 (PDF, 235KB, 8 pages)

Agency Board minutes: July 2014 (PDF, 223KB, 7 pages)

Agency Board minutes: June 2014 (PDF, 222KB, 6 pages)

Agency Board minutes: April 2014 (PDF, 231KB, 8 pages)

Agency Board minutes: March 2014 (PDF, 219KB, 6 pages)

Agency Board minutes: February 2014 (PDF, 225KB, 7 pages)

Agency Board minutes: January 2014 (PDF, 292KB, 6 pages)

Agency Board minutes: December 2013 (PDF, 286KB, 5 pages)

Agency Board minutes: October 2013 (PDF, 219KB, 6 pages)

CET minutes: 8 December 2015 (PDF, 222KB, 8 pages)

CET minutes: 5 January 2016 (PDF, 155KB, 6 pages)

Older minutes are available on the National Archives website.

Dates of public sessions of the Board in 2020

  • 27 April
  • 20 May
  • 23 July
  • 21 September
  • 23 November
  • 18 December

Open session of Board meeting on 27 April 2020

The Board, chaired by Sir Michael Rawlins, will open part of its next meeting on Monday, 27 April (10.30 am - 12.30 pm) to members of the public.

The meeting on 27 April will take place at the Agency’s office:

10 South Colonnade
Canary Wharf
London
E14 4PU

As with previous public Board meetings, the meeting will be divided into two sessions – the public session, followed by a private session later in the afternoon.

By necessity, discussion of matters of policy in development, commercial or staff confidentiality, certain emerging regulatory issues, forthcoming announcements or publications, will be dealt with in the private session.

Information note - Board meeting (public session) 27 April 2020 (PDF, 109KB, 1 page)

Item 05 - CEO's Report for October and November 2019 (PDF, 332KB, 17 pages)

Item 07 - Update on Patient and Public Engagement consultation (16 December 2019) (PDF, 84.4KB, 2 pages)

Item 07 - Update on Patient and Public Engagement consultation (16 December 2019) - interim findings (PDF, 123KB, 1 page)

Item 08 - Adverse Drug Reaction (ADR) reporting by patients (PDF, 353KB, 7 pages)

Item 09 - Timetable for Annual Report 2019/20 (Content) (PDF, 90.6KB, 3 pages)

Item 09 - Timetable for Annual Report 2019/20 (Cover note) (PDF, 80.1KB, 1 page)

Item 06 - MHRA's support for academics and SMEs developing innovative medicines and medical devices (PDF, 237KB, 5 pages)

Q&A during the meeting

Members of the public will have an opportunity to ask questions at the end of each discussion item at the discretion of the Chair.

For the meeting on 27 April, we have space for up to ten members of the public to attend.

To register for the public Board meeting on 27 April, please email directorate@mhra.gov.uk by the end of Sunday 19 April.

Places will be allocated on a first come first serve basis. In view of the limited spaces available, it will not be possible to gain entry to the public session on the day of the meeting unless you have registered before the deadlines above.

Papers for Board meeting (public session) 16 September 2019

Minutes

Item 03 Minutes Board 22 July 2019 Public Session Final (PDF, 99.1KB, 6 pages)

Agenda

Agenda 160919 (PDF, 109KB, 1 page)

Papers

Item 05 CEOs Report July and August 2019 (PDF, 279KB, 15 pages)

Item 06 IES Criminal Enforcement within the MHRA (PDF, 222KB, 7 pages)

Item 06 IES Criminal Enforcement within the MHRA cover note (PDF, 122KB, 1 page)

Item 07 NIBSC Highlights from 2018-19 (PDF, 146KB, 8 pages)

Item 08 Annex A Q1 BP report 2019-20 September Board Annex A (PDF, 274KB, 19 pages)

Item 08 Annex B Q1 BP Tracker (PDF, 81.5KB, 2 pages)

Item 08 Business Plan Q1 cover note (PDF, 113KB, 4 pages)

Item 09 Annex A Medicines and Healthcare products Regulatory Agency (MHRA)_Aoa_2019-20 (PDF, 1.68MB, 17 pages)

Item 09 Annex B 1E annual-board-report-and-statement-of-compliance 2019 for appraiser network (PDF, 256KB, 14 pages)

Item 09 Annex C Clinical governance handbook 1905 (PDF, 2.27MB, 36 pages)

Item 09 Responsible Officers and Revalidation cover note (PDF, 116KB, 5 pages)

Item 10 Digital and social media trends (PDF, 113KB, 4 pages)

Item 05 CEOs Report July and August 2019 (PDF, 279KB, 15 pages)

Item 06 IES Criminal Enforcement within the MHRA (PDF, 222KB, 7 pages)

Item 11 Pre-submitted questions to the Board (PDF, 108KB, 2 pages)

MHRA Board Meeting: April 2019

Minutes

Item 3: Agency board minutes: 15 April 2019 (PDF, 204KB, 7 pages)

Agenda

Agency board agenda: 15 April 2019 (PDF, 118KB, 1 page)

Papers

EAMS (PDF, 114KB, 3 pages)

CEOs Report - April 2019 (PDF, 255KB, 12 pages)

Innovation office (PDF, 294KB, 8 pages)

WEB-RADR (PDF, 112KB, 5 pages)

Attendance of a lay representative (PDF, 65.7KB, 2 pages)

MHRA Board Meeting: October 2018

Papers

Agency Board minutes: 22 October 2018 (PDF, 180KB, 9 pages)

Agenda

Papers

Members of the public and staff observers will have an opportunity to ask questions at the end of each item at the discretion of the Chair.

MHRA Board Meeting: 23 April 2018

Information note for MHRA's public board meeting - 23 April 2018 (MS Word Document, 28KB)

Agenda and Papers - Board meeting 23 April 2018 Part 1 - Public Session (PDF, 714KB, 45 pages)

MHRA Board Meeting: 15 December 2017

Information note for MHRA's public board meeting - 15 December 2017 (PDF, 284KB, 1 page)

Agenda Part 1 public session 15 December 2017 (PDF, 84.7KB, 2 pages)

Item 4: Minutes of 20 October Public Session (PDF, 233KB, 9 pages)

Item 7: CEOs Report (PDF, 424KB, 14 pages)

Item 8: Next Corporate Plan 2018 - 2023 (PDF, 294KB, 1 page)

Item 9: Operational transformation (PDF, 159KB, 5 pages)

Item 10: Implementation of EU legislation for medical devices and IVDS (PDF, 84.5KB, 3 pages)

Item 11: The Patient Safety and Vigilance Strategy Update (PDF, 330KB, 9 pages)

Item 12: Board / Executive interaction – update (PDF, 221KB, 5 pages)

Item 13: Annual Report and Accounts 2017/18 (PDF, 73KB, 2 pages)

Item 14: Board / Corporate Executive Team away day (PDF, 89.1KB, 2 pages)

MHRA Board meeting: 20 October 2017

Information note for MHRA's public board meeting - 20 October 2017 (PDF, 283KB, 1 page)

Agenda Part 1 public session 20 October 2017 (PDF, 116KB, 1 page)

Item 4: Minutes of 24 April Public Session (PDF, 381KB, 7 pages)

Item 7: Chief Executive's report for September 2017 (PDF, 381KB, 11 pages)

Item 9: Early Access to Medicines (EAMS) and Innovation Office Progress report (PDF, 289KB, 7 pages)

Item 10: Operation Pangea 2017 - update (PDF, 142KB, 3 pages)

Item 11: Equality and Diversity – Annual Board Update (PDF, 386KB, 10 pages)

20 October: Operational Transformation (PDF, 244KB, 5 pages)

Board Minutes: 20 October 2017 (PDF, 249KB, 9 pages)

MHRA Board meeting: 24 April 2017

Information note for MHRA’s Board meeting (in public session) - 24 April 2017 (PDF, 314KB, 1 page)

Agenda Part 1 public session - 24 April 2017 (PDF, 114KB, 1 page)

Item 4: Minutes of 12 December Public Session (PDF, 407KB, 7 pages)

Item 7 - Chief Executive's report for March 2017 (PDF, 516KB, 13 pages)

Item 8 - Update on Pharmacovigilance Projects (PDF, 600KB, 31 pages)

Item 9: Update on Global Communications Programme (PDF, 116KB, 6 pages)

Item 10 - International Strategy cover sheet (PDF, 88.2KB, 2 pages)

Item 10 - International Strategy (PDF, 462KB, 17 pages)

Item 11: Agency’s Risk Appetite Statement (PDF, 141KB, 4 pages)

Minutes Public Board 24 April 2017 (PDF, 408KB, 7 pages)

MHRA Board meeting: 12 December 2016

Agenda item 4: Minutes of September board public session (PDF, 421KB, 9 pages)

Agenda item 8: Talent Management Initiative update (PDF, 105KB, 5 pages)

Agenda item 9: Apprenticeships update (PDF, 103KB, 4 pages)

Agenda item 13: Annual Report and Accounts 2016-17 (PDF, 83.4KB, 2 pages)

Agenda item 10: NIBSC highlights (PDF, 164KB, 6 pages)

Agenda item 12: The Board's Terms of Reference (PDF, 155KB, 4 pages)

Agenda item 7: CEO's Report for November 2016 (PDF, 452KB, 15 pages)

Agenda item 13: Annex 1 (PDF, 65.7KB, 1 page)

Agenda item 11: Finance and Procurement Report (PDF, 913KB, 13 pages)

Agenda item 13: Annex 2 (PDF, 27.9KB, 2 pages)

Agenda item 13: Annex 3 (PDF, 462KB, 2 pages)

Agency Board minutes: 14 October 2016 (PDF, 215KB, 7 pages)

Agency Board minutes: 14 November 2016 (PDF, 241KB, 9 pages)

If you are interested in attending, please email: directorate@mhra.gov.uk by 5.00 pm on Monday, 5 December to register.

MHRA Board meeting: 12 September 2016

Agenda item 9: YC Collaboration with the National Poisons Information Service (PDF, 59.4KB, 11 pages)

Agenda item 4 :Minutes of the Board meeting – public session11 April 2016 (PDF, 61.9KB, 9 pages)

Agenda item 10: Working with the Devolved Administrations (PDF, 30.9KB, 7 pages)

Agency Board minutes: 12 September 2016 (PDF, 422KB, 9 pages)

Agenda Part 1 - Public Session 12 December 2016 (PDF, 112KB, 1 page)

Agenda item 11: People Strategy 2014-2019 (refreshed 2016) (PDF, 78KB, 17 pages)

Agenda item 13: Quarterly report – BP Monitoring Report Q1 2016-17 (PDF, 185KB, 4 pages)

Quarterly report – BP Monitoring Report - Annex A (PDF, 228KB, 3 pages)

Agenda item 8: Strategic Direction for Medicines Information (PDF, 232KB, 12 pages)

Quarterly report – BP Monitoring Report - Annex B (PDF, 277KB, 7 pages)

Quarterly report – BP Monitoring Report - Annex C (PDF, 42.8KB, 3 pages)

Quarterly report – BP Monitoring Report - Annex D (PDF, 89.5KB, 1 page)

Agenda item 12: Finance & Procurement Monthly Report (PDF, 1.69MB, 14 pages)

Agenda item 7: CEO's Report (PDF, 109KB, 13 pages)

MHRA Board meeting: 11 April 2016

Item 6: CEO's report (PDF, 415KB, 13 pages)

Agency Board minutes: 12 February 2016 (PDF, 177KB, 5 pages)

Item 7: Innovation office - questions from the public (PDF, 392KB, 6 pages)

Item 8: Joint patient safety and vigilance strategy (PDF, 195KB, 10 pages)

Item 9: People survey report (PDF, 167KB, 3 pages)

Item 10: Digital information management - Annex A (PDF, 318KB, 9 pages)

Item 10: Digital information management (PDF, 114KB, 6 pages)

Glossary- Commonly used words, phrases and abbreviations (PDF, 267KB, 30 pages)

Item 11: Budget 2016 - 2017 (PDF, 692KB, 31 pages)

Item 12: Finance and Procurement report (PDF, 3.17MB, 32 pages)

Item 13: Note of March 2015 ARAC meeting (PDF, 400KB, 12 pages)

Item 9: People survey report (PDF, 537KB, 1 page)

Information note for MHRA’s board meeting (in public session) (PDF, 308KB, 1 page)

Agency Board minutes: 11 April 2016 (PDF, 318KB, 9 pages)

MHRA Board meeting: 12 February 2016

You can download papers from the 12 February 2016 Board Meeting in our filecamp folder.

Corporate Executive Team (CET)

The Corporate Executive Team (CET) - previously the Executive Board - is the highest executive decision-making body of the Agency. The CET is chaired by the Interim Chief Executive, Dr June Raine, and is made up of:

  • the directors of each of the MHRA’s divisions
  • the director of the National Institute for Biological Standards and Control (NIBSC)
  • the director of the Clinical Practice Research Database (CPRD)
  • a representative from the Department of Health Legal Services

The CET has overall responsibility for:

  • day-to-day management
  • strategic decision-making
  • line management
  • all financial, policy, operational and resource management issues

Full details of the CET’s responsibilities can be found in our terms of reference.

Corporate Executive Team (CET) declarations of interest

CET directors' declarations of interests (PDF, 66.7KB, 2 pages)

Conflicts of interest between our 3 constituent groups

The work carried out by the MHRA, the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD) is closely linked. Since our merger we know that some of the work NIBSC and CPRD do may need to be regulated by the MHRA. We know that this is a potential conflict of interest because of our close relationship. To help deal with these situations, we have produced a policy for handling conflicts of interest.