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Human Medicines Regulations 2012 Advisory Bodies Annual Report 2015

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Human Medicines Regulations 2012 Advisory Bodies Annual Report 2015 Human Medicines Regulations 2012 Advisory Bodies Annual Report 2015 Commission on Human Medicines British Pharmacopoeia Commission Medicines & Healthcare products Regulatory Agency HUMAN MEDICINES REGULATIONS 2012 ADVISORY BODIES ANNUAL REPORT 2015 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: Wenisa Cheung Expert Committee Support 151 Buckingham Palace Road London SW1W 9SZ 020 3080 6060 © Crown copyright 2016 Published by the Medicine & Healthcare products Regulatory Agency ISBN 978-1-900731-15-7 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence. To view this licence, visit nationalarchives.gov.uk/doc/open-government- licence/version/2/ or email [email protected] Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Any enquiries regarding this publication should be sent to the MHRA at: Medicines & Healthcare products Regulatory Agency Information Services 151 Buckingham Palace Road London SW1W 9SZ 020 3080 6000 E-mail: [email protected] You can download this publication from https://www.gov.uk/mhra LIST OF CONTENTS Foreword ii Report on the Commission on Human Medicines 1 Report of the British Pharmacopoeia Commission 117 Code of Practice for Chairmen and Members of the Commission on Human 138 Medicines, Certain Committees and Expert Advisory Groups Members’ Interests: Commission on Human Medicines 149 Cardiovascular, Diabetes, Renal, Respiratory and Allergy Expert 170 Advisory Group Chemistry, Pharmacy and Standards Expert Advisory Group 177 Clinical Trials, Biologicals & Vaccines Expert Advisory Group 180 Gastroenterology, Rheumatology, Immunology and Dermatology Expert 189 Advisory Group Infection Expert Advisory Group 192 Medicines for Women’s Health Expert Advisory Group 194 Neurology, Pain and Psychiatry Expert Advisory Group 196 Oncology and Haematology Expert Advisory Group 201 Paediatric Medicines Expert Advisory Group 209 Patient and Public Engagement Expert Advisory Group 215 Pharmacovigilance Expert Advisory Group 223 External Expert Panel 225 Ophthalmic External Expert Panel 234 Alteplase Working Group 239 Anti-Epileptic Drugs Working Group 244 Hormonal Pregnancy Tests Working Group 252 British Pharmacopoeia Commission 258 i FOREWORD BY THE PARLIAMENTARY UNDER SECRETARY OF STATE FOR LIFE SCIENCES It gives me great pleasure to present the Annual Reports for 2015 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. 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 ii COMMISSION ON HUMAN MEDICINES ANNUAL REPORT 2015 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 Secretary of State for Health and the Northern Ireland Minister for Health, Social Services and Public Safety (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 EU legislation applies. MEMBERSHIP 3. Commissionersʼ details are listed at Appendix I. There are currently 11 EAGs that report to the Commission, their remits and membership are listed at Appendix II. 4. The Commission warmly congratulates Professor Sir Munir Pirmohamed, member of the CHM and Chair of the Pharmacovigilance EAG, on receiving a knighthood in the 2015 Birthday Honours List. 5. The Commission also warmly congratulates Professor Sir Ian Weller, Chair of the Alteplase Working Group and former vice-chair of the CHM, on receiving a knighthood in the 2015 Birthday Honours List. 1 1 6. The Commission warmly congratulates Professor Helen Cross, member of the Paediatric Medicines EAG and the Anti-Epileptic Drugs Working Group, on receiving an OBE in the Queen's Birthday Honours. 7. The Commission warmly congratulates Professor Kevin Park on the award of the British Pharmacological Society’s Lilly Prize for distinction in clinical pharmacology. 8. The Commission wishes to record its gratitude and appreciation of the valuable work of its Expert Advisory Groups and Working Groups listed below. Members’ details are listed at Appendix II. Expert Advisory Groups 2015 Cardiovascular, Diabetes, Renal, Respiratory and Allergy (CDRRAEAG) Chaired by Dr J Colin Forfar Chemistry, Pharmacy and Standards (CPSEAG) Chaired by Professor Kevin M G Taylor Clinical Trials, Biologicals & Vaccines (CTBVEAG) Chaired by Professor Angela E Thomas Gastroenterology, Rheumatology, Immunology & Dermatology (GRIDEAG) Chaired by Professor Anthony G Wilson Infection (IEAG) – formerly Anti-Infectives, HIV/AIDS and Hepatology (AIHHEAG) Chaired by Professor Jonathan Friedland (from 17th July 2015) Medicines for Women’s Health (MWHEAG) Chaired by Dr Ailsa Gebbie Neurology, Pain & Psychiatry (NPPEAG) Chaired by Professor David G C Owens Oncology and Haematology (OHEAG) Chaired by Professor Martin Gore Paediatric Medicines (PMEAG) Chaired by Dr Rebecca Mann Patient and Public Engagement (PPEEAG) Chaired by Mr Harry Cayton (from 1st January until 29th January 2015) Chaired Pro Tem by Mr Phil Willan (from 30th January 2015) 2 Pharmacovigilance (PEAG) Chaired by Professor Sir Munir Pirmohamed Working Groups 2015 Alteplase Working Group Chaired by Professor Sir Ian Weller Anti-Epileptic Drugs Working Group Chaired by Professor Malcolm Macleod Hormonal Pregnancy Tests Working Group Chaired by Dr Ailsa Gebbie 9. The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency’s (EMA) committee responsible for preparing the Agency's opinions on all questions concerning medicines for human use. The Commission notes with great pleasure the extent of its influence within the CHMP’s Scientific Advisory Groups (SAGs). Commissioners, EAG members and Working Group members serving as SAG members are as follows: • Professor Deborah Ashby (Cardiovascular Issues SAG) • Dr J Colin Forfar (Cardiovascular Issues SAG) • Professor Martin Gore (Inter-Committee SAG on Oncology) • Dr Anthony Johnson (Neurology SAG) • Professor Malcom Macleod (Neurology SAG) • Professor Elizabeth Miller (Vaccines SAG) • Professor David G C Owens (Psychiatry SAG) • Professor Andrew Pollard (Vaccines SAG - Chair) • Professor Robert C Read (Anti-Infectives SAG) • Dr Siraj Misbah participated in the Neurology SAG during November 10. Professor B Kevin Park retired from his role as a member of CHM in December. Professor Park has served as a member of CHM since 2005 and was a member of its predecessor, the Committee on Safety of Medicines, from 1993 to 2005. The Commission wishes to place on record its sincere gratitude to Professor Park for his outstanding contribution over 25 years, including his membership of nine Subcommittees, Expert Advisory Groups and Working Groups of the CSM and CHM. 11. Lady Carolyn Roberts retired from her role as a member of CHM in October. The Commission wishes to extend its thanks to Lady Roberts for her valued contribution to the work of CHM, its Expert Advisory Groups and Working 3 Groups, which has spanned over 11 years in total. Lady Roberts will continue to contribute to the work of the Commission via the MWHEAG and PPEEAG. 12. Professor Simon Thomas retired from his role as a member of CHM in December. The Commission wishes to extend its thanks to Professor Thomas for his valued contribution to the work of the CHM, its Expert Advisory Groups and Working Groups, as well as the CSM and its Subcommittees, which has spanned over 15 years in total. 13. The Commission wishes to record its gratitude to those members of its External Expert Panel and Ophthalmic Panel who attended meetings or provided written advice to the Commission and its Expert Advisory Groups during the course of the year. Members’ details are listed at the end of this report at Appendix III. MEETINGS 14. The Commission held 11 meetings during 2015. Two day meetings were held in February, April, July, September, October and November. One day meetings normally lasted between five and six hours. Meetings were held at the Medicines and Healthcare
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