Department of Health triennial review of arm’s length bodies
1 December 2014
The Department of Health (DH) reviews its arm’s length bodies once every 3 years.
This review is looking at what MHRA, the British Pharmacopeia and the Commission on Human Medicines do and how.
DH has sent out a public call for evidence to support the reviews.
- British Pharmacopoeia Commission: triennial review (external link)
- Commission on Human Medicines: triennial review (external link)
- MHRA: triennial review (external link)
Breast Implant Survey
The Clinical Practice Research Datalink (CPRD) is undertaking a survey aimed at women who have had or who are contemplating having breast implants. CPRD is currently running a pilot study to inform a wider Department of Health backed piece of work to develop a breast implant registry.
This survey is an important part of that work. The aim of an ongoing breast implant registry is to ensure that all women with breast implants can be contacted should any safety concerns with their implant arise in the future. It will also enable research on the outcomes of this surgery, to enable a better understanding of risks of breast implants.
The survey is anonymous and will take no longer than 10 minutes to complete. It includes questions on how acceptable women find the idea of a registry, how they would like information on the registry to be provided and how they would like to update their details. This survey will inform the wider project; completing the survey does not mean that patient details will be registered.
Please click here to go to the survey. It will be open until 06/01/2015.
FDA Commissioner to speak at MHRA Annual Lecture
The Medicines and Healthcare Products Regulatory Agency hosts an Annual Lecture for an invited audience including senior figures in medicine, government, academia and industry. It provides an opportunity to meet and network with staff, and hear from international experts on important issues in the wider societal context of medical product regulation and advances and challenges in science and research.
This year, the MHRA welcomes Dr Margaret A. Hamburg, who will be offering her perspective on an international theme around the challenges presented by globalisation over the next 10 to 15 years and the collaborative efforts of regulators internationally to respond. Dr Hamburg is the Commissioner of the US Food and Drug Administration (FDA) and has provided leadership in this field.
Dr Hamburg will cover six main themes in this year’s lecture:
- Challenges presented by globalisation over the next 10-15 years and the collaborative efforts of regulators internationally to respond to these
- Scientific collaboration between regulators
- Use of real world data
- Smart regulation in a changing world
- Challenges posed by rapid advances in science and technology and supporting innovation
- Importance of collaboration
Debate and discussion will continue at the drinks reception which will follow the lecture.
Updated CPRD ISAC Applications Guidance
TThe Guidance on the content of CPRD ISAC applications has been updated and can be found under the ISAC section of our website. A PDF copy is also available for download. Click here for more information
ISAC audit of publications
The ISAC will be undertaking an audit of all publications in 2013 which resulted from studies using CPRD data. The primary purpose of the audit is for ISAC to better understand the level of concordance between approved protocols and the resultant studies. The ISAC guidance on amendments to approved protocols is available under the ISAC section of our website.