The Human Medicines Regulations 2012 came into force on 14 August 2012
The Human Medicines Regulations 2012 came into force on 14 August 2012. The regulations are the result of the initiative by the Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation.
The regulations significantly simplify medicines legislation while maintaining strong and effective safeguards for public health. They will also reduce regulatory burden on business. They replace much of the Medicines Act 1968 and around 200 statutory instruments, in the process repealing much obsolete law and contributing to the government’s drive for burden reduction.
They also introduce some small policy changes to help ensure that the legislation remains fit for purpose and reflects modern practice. These relate to the removal of statutory warnings for packaging; improvements to the process for review hearings; updating of sale, supply and administration exemptions and of provisions for patient group directions; and optimisation of medicines use.
In addition, the regulations include provisions to implement new EU legislation on pharmacovigilance. These provisions introduce a strengthened, clarified and more proportionate regime for monitoring the safety of medicines to ensure a high level of public health protection across the EU.
International Clinical Trials Day: 20 May 2012
International Clinical Trials Day takes place on 20 May each year, raising awareness of the importance of trials to health care. It highlights how partnerships between patients and practitioners are vital to high quality, relevant clinical trials; such as those funded by the National Institute for Health Research (NIHR). Events have been organised by the European Clinical Research Infrastructures Network (ECRIN) and a series of podcasts has been compiled by The Cochrane Collaboration.
This collection of evidence pods includes information on how the mega-trials of the last two decades have shown that the recruitment of 20,000 or more patients to a high priority study, such as the NIHR-funded CRASH-2 trial, can have a major impact on the care of millions of other people. It has been prepared in collaboration with the MRC’s Network of Hubs for Trials Methodology Research, highlighting the role of the Network for conducting and disseminating research into the conduct of trials.
Attributing the costs of health & social care Research & Development: 4 May 2012
Guidance on attributing costs for research
The Department and the Association of Medical Research Charities (AMRC) announce the publication of new guidelines for attributing the costs of health and social care research and development (AcoRD).
AcoRD establishes a mechanism for the Department to meet some of the costs of charity-funded research in the NHS, for charities that are members of AMRC. The agreement recognises the unique contribution medical research charities make to excellent research in the NHS – of the over 3,000 clinical studies conducted in the NHS in 2009-10, 37 per cent were funded by AMRC member charities and charities spend more than £1bn on research each year.
Health research is a core NHS activity and the Health and Social Care Act (2012) puts research at the heart of the NHS for everyone. Public funders – the government, through the National Institute of Health Research (the research arm of the Department of Health) and Research Councils – and medical research charities working together with the private sector, make the NHS one of the world’s leading organisations for hosting clinical and applied health research. Through the AcoRD guidance the Department of Health has recognised that charities are a special case because their funds come from donations by patients and the public.
The AcoRD guidance clarifies the distinction between the three categories of costs associated with non-commercial research studies:
• Research Costs
• NHS Support Costs
• Treatment Costs.
Annex A provides an exemplar set of common activities that have been attributed to the three specific cost categories and Annex B provides a list of Frequently Asked Questions (FAQs). These Annexes will be updated on a regular basis and users need to ensure that they refer to the latest version when attributing the costs of research.
The AcoRD guidance supersedes earlier guidance contained in Attributing Revenue Costs of non-commercial research in the NHS (ARCO) and must be used to attribute the costs of research taking place in the NHS where the outline or full grant funding application is submitted to funders from 1 October 2012. The AcoRD guidance should not be applied retrospectively to studies contracted prior to 1 October 2013 where the full application for funding was submitted before 1 October 2012.
NRES Standard Operating Procedures (SOPs) for Research Ethics Committees in the UK - April 2012
Version 5.1 of the NRES Standard Operating Procedures (SOPs) for Research Ethics Committees in the UK came into effect on 1 April 2012.
Public Consultation on Pharmacovigilance (MLX 374) - January 2012
Re: Transposition of Pharmacovigilance Directive 2010/84/EU
Consultation MLX374 seeks your views on the draft regulations transposing the EU Directive 2010/84/EU on Pharmacovigilance. This Directive must be transposed to UK law by 21 July 2012. This is accompanied by EU Regulation 1235/2010/EU on Pharmacovigilance, to be transposed by 2 July 2012. Comments are invited by 28 February 2012.
The Joint R&D Support Office and Research Goverance - 12 & 16 January 2012
MHRA inspection questionnaire results 2011 - December 2011
The results of the Good Clinical Practice stakeholders inspection questionnaire 2011 are now available on the MHRA website:
Guidance on risk-proportionate approaches to the management and monitoring of clinical trials - 12 October 2011
The concept of risk adaptation was implemented by the MHRA for UK trials on the 1 April 2011. Guidance on risk-proportionate approaches to the management and monitoring of clinical trials has now been published as Appendix 2 of the MRC/DH/MHRA Joint Project document 'Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products'
MHRA consultation on consolidated medicines legislation excludes clinical trials
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a formal public consultation on the consolidation of UK medicines legislation, which is intended to greatly simplify and clarify the law regulating medicines in the UK.
The current body of UK medicines legislation comprises the Medicines Act 1968 and approximately 200 statutory instruments. It has developed piecemeal since the Medicines Act 1968 came into force some 40 years ago and is fragmented, complex and often difficult to follow.
However, the proposed legislation specifically excludes clinical trials from its scope, stating in item 4.10 of the consultation document: "There are ongoing negotiations at European level about the introduction of a Directive that would require substantial changes to the regulation of clinical trials... We intend to leave the existing UK legislation regulating clinical trials as it is for the moment, rather than consolidate it now and then amend it substantially not long afterwards."
The consultation ML X375 is open for 12 weeks, and comments are invited by Tuesday 17 January 2012.
"Core areas for measurement: are there things that we should measure in ALL clinical trials?" seminar by Prof Maarten Boers - 27 October 2011
The CTU and the NIHR Research Design Service for the East Midlands jointly hosted a super seminar for the Department of Health Sciences. Professor Maarten Boers, Professor of Clinical Epidemiology, VU University Medical Center, Amsterdam provided a presentation on "Core areas for measurement: are there things that we should measure in ALL clinical trials?"
"Health Research Authority" legislation laid before UK Parliament - 28 September 2011
Secondary legislation to create a "Health Research Authority" for England has been laid before the UK Parliament. Unless overturned, it will take effect on 1 December 2011.
Establishment of the new Health Research Authority (HRA) follows a recommendation from the Academy of Medical Sciences (AMS) review chaired by Prof. Sir Michael Rawlins, reported in January 2011. The HRA will take over functions of the National Patient Safety Agency in relation to RECs, presumably by absorbing NRES as a part of its structure. The IRAS application system and the research ethics committee database (RED) will be transferred to the HRA.
The details of the new organisation and the extent of its powers and budget are not set out in this legislation, so will need to be clarified over the coming months.
European Commission revises adverse event reporting guidance - 14 Jun 2011
This revision replaces the following three documents:
• "Revision 2 of the Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)";
• The "Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance - Clinical Trial Module)"; and
• The "Questions & Answers specific to adverse reaction reporting in clinical trials"
Governance Arrangements for Research Ethics Committees (GAfREC): a harmonised edition - May 2011
Following the consultation initiated by the UK Health Departments in 2009, the harmonized UK-wide version of the Governance Arrangements for Research Ethics Committees (GAfREC) has now been finalised and published on the Department of Health website at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_126474
The new version of GAfREC will come into effect on 1 September 2011. It is being published in advance to allow all concerned to familiarize themselves with it, and to enable NRES, R&D offices and other organizations to develop supporting guidance and modify their procedures where necessary. In the meantime, the current version of GAfREC continues to apply.
The NRES website will be updated in due course, in particular to reflect the revised requirements for ethical review which will apply from 1 September 2011.
The current revision of the NRES Standard Operating Procedures will take account of the provisions of the new GAfREC. NRES expects to issue version 5.0 of the SOPs in June 2011, though with implementation of some aspects of the SOPs deferred until 1 September 2011.
MHRA Stakeholder Questionnaire - May 2011
The MHRA is considering publishing a Good Clinical Practice guidance, and has developed a questionnaire to gauge stakeholder opinion on the usefulness and content of this guide. The questionnaire and covering letter can be accessed via the links below. Completed questionnaires should be sent to Kathleen Meely (Senior GCP Inspector, contact details in questionnaire) by 31 May 2011.
Launch of the DH/MHRA/MRC risk-adapted approach to CTIMPs - April 2011
It is proposed that the risks associated with an IMP can be categorised based on the marketing status of the IMP and its use in standard medical care. Using a simple categorisation of three risk types it will be possible to highlight lower risk trials where simplification in risk management is possible.
The Notification Scheme will be open to trials involving medicinal products authorised in any EU Member State if:
• they relate to the licensed range of indications, dosage and form, or
• they involve off-label use (such as in paediatrics and oncology, etc) if this off-label use is established practice and supported by sufficient published evidence and/or guidelines.
Following receipt of a valid notification of submission, sponsors will receive an acknowledgement letter to say that the trial may go ahead after 14 days from receipt of the notification if the MHRA has not raised any objections i.e. the acknowledgement letter will act as the authorisation.
The risk assessment and associated trial management/monitoring plan developed to minimise these risks will form the basis of a common understanding by all stakeholders on the risks for that trial, and facilitate a risk-proportionate approach to the trial activities. Stakeholders include the regulators, the sponsor, the funder and the healthcare organisations/host sites.
The proposed risk assessment process should be initiated by the chief investigator/protocol author at an early stage in protocol development. It should also be reviewed by other key stakeholders, such as the sponsor, funders and other investigators, to agree on the main risks inherent in the trial protocol. A plan to mitigate or manage these risks should be developed, either as part of the trial protocol or outlined in associated documents (such as a monitoring plan). Once developed, it is envisaged that the risk assessment and associated mitigation/monitoring plans will form the basis of a common understanding and dialogue by all stakeholders on the risks for that trial, and allow for a risk-proportionate approach to all trial activities.
Leicester Clinical Trials Unit Acquires MACRO CDMS - December 2010
The CTU has acquired and installed the latest release of the Infermed MACRO Electronic Data Capture and Clinical Data Management System (v4.1). The system is currently undergoing operational qualification testing and will be fully operational by the end of March 2011. It will be implemented as new trials open.
Leicester Clinical Trials Unit UKCRC Provisional Registration - December 2009