Human Medicines Regulations 2012 Advisory Bodies Annual Report 2014

266 Pages·2015·1.84 MB·English

by  Norris, Fay

Human Medicines
Regulations 2012
Advisory Bodies

Annual Report 2014

Commission on Human Medicines

British Pharmacopoeia Commission

Medicines & Healthcare products Regulatory Agency

HUMAN MEDICINES REGULATIONS
2012
ADVISORY BODIES ANNUAL
REPORT 2014

Presented to Parliament pursuant to Part 2, Section
12 (2) of
the Human Medicines Regulations 2012

Commission on Human Medicines

British Pharmacopoeia Commission
Contact for information about these reports:
Fay Norris
151 Buckingham Palace Road
020 3080 6060

© Crown copyright 2015
Published by the Medicine & Healthcare products Regulatory
Agency

ISBN 978-1-900731-14-0

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LIST OF CONTENTS

Foreword ii
Report on the Commission on Human Medicines 1
Report of the British Pharmacopoeia Commission 108
Code of Practice for Chairmen and Members of the Commission on Human
127
Medicines, Certain Committees and Expert Advisory Groups
Members’ Interests:
Commission on Human Medicines 138
Anti-Infectives, HIV and Hepatology Expert Advisory Group 149
Cardiovascular, Diabetes, Renal, Respiratory and Allergy Expert
152
Advisory Group
Chemistry, Pharmacy and Standards Expert Advisory Group 160
Clinical Trials, Biologicals & Vaccines Expert Advisory Group 163
Gastroenterology, Rheumatology, Immunology and Dermatology Expert
176
Advisory Group
Medicines for Women’s Health Expert Advisory Group 181
Neurology, Pain and Psychiatry Expert Advisory Group 184
Oncology and Haematology Expert Advisory Group 190
Paediatric Medicines Expert Advisory Group 193
Patient and Public Engagement Expert Advisory Group 200
Pharmacovigilance Expert Advisory Group 208
External Expert Panel 210
Ophthalmic External Expert Panel 220
Alteplase Working Group 225
Isotretinoin and Psychiatric Working Group 229
National Emergency Stockpile Quality Panel 235
Nicotine Containing Products Working Group 238
Review of Non-Prescription Analgesics Working Group 243
Sodium Valproate Working Group 246
British Pharmacopoeia Commission 253

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FOREWORD BY THE PARLIAMENTARY UNDER
SECRETARY OF STATE FOR LIFE SCIENCES

It gives me great pleasure to present the Annual Reports for 2014 of the Human
Medicines Regulations Advisory Bodies: the Commission on Human Medicines and
the British Pharmacopoeia Commission. These reports include a record of Members’
interests in the pharmaceutical industry and code of practice.

I also take great pleasure in recognising 2014 as a landmark year for the British
Pharmacopoeia, marking 150 years since publication of the first edition.

On behalf of all Health Ministers I would like to thank the Chairs and Members of
both Expert Committees and all those who contribute to their many expert advisory
groups and working parties whose professional expertise, commitment and hard
work plays a vital role in ensuring that the medicines we take continue to meet the
highest standards of safety, quality and efficacy.

George Freeman

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COMMISSION ON HUMAN MEDICINES ANNUAL
REPORT 2014

TERMS OF REFERENCE

1. The Commission on Human Medicines was established in October 2005. Its
functions are set out in regulation 10 of the Human Medicines Regulations 2012
(SI 2012/1916).

2. The functions of the Commission on Human Medicines are:

• to advise the Health Ministers and the Licensing Authority (LA) on
matters relating to human medicinal products including giving advice in
relation to the safety, quality and efficacy of human medicinal products
where either the Commission thinks it appropriate or where it is asked to
do so;

• to consider those applications that lead to LA action as appropriate (i.e.
where the LA has a statutory duty to refer or chooses to do so);

• to consider representations made (either in writing or at a hearing) by an
applicant or by a licence or marketing authorisation holder in certain
circumstances;

• to promote the collection and investigation of information relating to
adverse reactions to human medicines for the purposes of enabling
such advice to be given.

The Commission is similarly involved in respect of medicinal products to which
relevant EC legislation applies.

OBITUARY

3. It was with great sadness and regret that the Commission learnt of the death of
Professor Roger Griffin, a former member of the Chemistry Pharmacy and
Standards sub-committee and Expert Advisory Group from 2002-2009. He was
a much valued expert who made a significant contribution to the Commission’s
work and had limitless enthusiasm for his research work and development of
medicines.

APPOINTMENTS

4. In April 2014, the Secretary of State for Health made the following appointments
to the Commission:

Dr Jamie Fraser BSc MB ChB MRCGP
GP Partner, Southside Surgery, Inverness

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Professor Jonathan S Friedland MA PhD FRCP FRCPE FMedSci
Hammersmith Campus Director & Head of Section of Infectious Diseases &
Immunity, Imperial College London; Hon Consultant in Infectious Diseases ICHT

Professor Martin Gore MBBS PhD FRCP
Medical Director and Consultant Medical Oncologist, The Royal Marsden NHS
Foundation Trust and Professor of Cancer Medicine, Institute of Cancer
Research

Professor Malcolm R Macleod BSc MBChB MRCP PhD FRCP (Edin)
Professor of Neurology and Translational Neurosciences, University of Edinburgh
and Honorary Consultant Neurologist, NHS Forth Valley

Dr Rebecca Mann BMBS FRCPCH
Consultant Paediatrician, Taunton and Somerset NHS Foundation Trust

Professor Shirley Price MSc PhD FBTS ERT FHEA FSB
Head of Academic Appeals and Academic Quality and Professor of Toxicology,
University of Surrey.

5. In December 2014, the Secretary of State for Health made the following
appointments to the Commission:

Mrs Eileen J Barrett BSc PGCE CPE LPC
HR and Legal Director, Source BioScience, Nottingham

Dr Richard Gilson MD FRCP
Director, Centre for Sexual Health & HIV Research and Head, Research
Department of Infection and Population Health, University College London

Dr Sarah Meredith
Deputy Director, MRC Clinical Trials Unit and Honorary Senior Lecturer,
Department of Primary Care and Population Sciences, University College
London

Dr Christopher Weir BSc (Hons) PhD MSc FRSS C.Stat C. Sci
Reader in Medical Statistics, Centre for Population Health Sciences, University
of Edinburgh

6. In January 2014, the following re-appointments to the Commission were made:

Dr J Colin Forfar BSc (Hons) MBChB PhD MD MA FRCP FRCP (Edin)
Consultant Physician and Cardiologist, John Radcliffe Hospital, Oxford

Professor B Kevin Park BSc PhD FMedSci FRCP (Hon) FBTS
Director of MRC Centre for Drug Safety Science, Professor of Pharmacology &
Head of Institute of Translational Medicine, University of Liverpool

Professor Munir Pirmohamed MB ChB (Hons) PhD FRCP FRCP (Edin)
FMedSci
Professor of Clinical Pharmacology, University of Liverpool, NHS Chair of
Pharmacogenetics and Director of the Wolfson Centre for Personalised
Medicine

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