Medicines and Healthcare products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency is focussed on protecting and promoting public health through its three centres: Clinical Practice Research Datalink (CPRD), National Institute for Biological Standards and Control (NIBSC) and MHRA.
Here are a few of our 2016 highlights from across the Agency.
Supporting innovation
MHRA supports innovation to help bring improvements in public health and encourages early dialogue with those developing new products. In 2016, our regulatory and scientific advice service arranged a record number of 377 meetings, where our experts provided advice on regulatory requirements, how to achieve quality product development, non-clinical testing and clinical trial designs.
MHRAs Innovation Office received 122 requests for advice in 2016. A large number of these had to do with innovative products, or interesting new concepts at an early stage of their development.
The number of first in human clinical trials carried out in the UK is also increasing. This is significant as this demonstrates that the UK Life Science sector remains strong and the UK remains a centre of excellence for carrying out initial clinical research activities. In 2016, MHRA assessed 58 first in human trials and 17 trials involving Advanced Therapy Medicinal Products (ATMP).
Ensuring the safety of medical devices
MHRA plays a key role in the regulation of medical devices by overseeing the essential work of the five UK Notified Bodies; together they are responsible for assessing the majority of devices currently placed on the EU market.
As part of our device surveillance work we issued more than 21 Medical Device Alerts (MDAs) and oversaw the publication of more than 889 Field Safety Notices (FSNs) issued by manufacturers in 2016.
One of our key pieces of work this year was providing updated guidance to help identify which health apps should be regulated as medical devices. We live in an increasingly digital world where healthcare professionals, patients and the public are using software and stand-alone apps to aid diagnosis and monitor health.
Our updated guidance issued in August will help protect people by helping developers decide which apps are medical devices and ensure they are appropriately validated, comply with regulations and are acceptably safe and effective.
#FakeMeds
This year, MHRA launched a public health campaign called #FakeMeds, aimed at educating 18-30 year old adults about how to buy medical products online safely. A substantial proportion of medicines sold online are fake or unlicensed, and were raising awareness of how to avoid these products. . Our campaign has been covered by Radio 1s The Surgery, BBCs The One Show and ITVs Coronation Street, The Sun, BBC Online, The Times and several regional papers. After working together on the Radio 1 appearance, the Agency also met up with celebrity doctor Dr Radha, who filmed videos to support our campaign.
You can view our social media activity by searching the hashtag #FakeMeds.
Cracking down on illegal sales of medical products online
MHRA is always working behind the scenes to stop the illegal sale of medicines and medical devices. Many online sites are selling illegal and potentially dangerous lifestyle medicines such as those for erectile dysfunction, and slimming pills.
This year, as part of the global Operation Pangea, we seized more than 13.6m worth of falsified and unlicensed medicines during this week of action in which we particularly targeted people in the UK who try and sell fake medicines online to unsuspecting members of the public.
Leading on medicines regulation
MHRA was elected to chair the International Coalition of Medicines Regulatory Authorities (ICMRA) for the next two years. This Coalition brings together key medicines regulators from all over the world to work together to jointly address common issues.
Providing data for vital health research
Over the last year CPRD has added more than 4 million patient records to their database of anonymised patient data. This brings their total number of patient lives to more than 21 million. This data will lead to improvements in drug safety, best practice and clinical guidelines.
Leading the change on e-cigarettes
Over the course of 2016 the new regulatory framework for e-cigarettes under the Tobacco Products Directive has been implemented by MHRA as the competent authority. We have now received more than 19,700 submissions.
Encouraging the reporting of suspected side effects to help make medicines safer
As part of our global role in promoting medicines safety, MHRA led an EU-wide social media campaign to promote adverse drug reaction (ADR) reporting and in the UK to increase awareness of the Yellow Card Scheme.
At the centre of the campaign is an animation created by MHRA showing the story of a patient who has a suspected adverse reaction to a medicine he/she was taking. It shows the medicine being taken, a suspected side effect being experienced, how reports are made by patients or healthcare professionals to the medicines regulator, and how this benefits future patients.
Following a week of action, we raised awareness with our animation being viewed more than 150,000 times and a 17% increase in Yellow Card reports.
Innovating analysis
In October 2016 we launched interactive Drug Analysis Profiles (iDAPs). Each iDAP provides complete data of all spontaneous suspected adverse drug reactions or side effects, which have been reported for a drug substance to MHRA, via the Yellow Card Scheme from either healthcare professionals or members of the public. They also include reports from pharmaceutical companies. iDAPs enable interaction with the data so that the types of reactions that have been reported can be understood, and at a high level understand more about who experienced the side effects.
iDAPs are currently available for 2150 active substances and more than 2300 visitors viewed the interactive profiles in November 2016 on www.yellowcard.mhra.gov.uk/idap.
The new iDAPs allows us to demonstrate greater transparency with regards to the data we collect from Yellow Card reports for licensed medicines. The data is also more clearly displayed and user friendly than the old static pdf files we previously published.
Feedback received from members of the public, healthcare professionals and the pharmaceutical industry has all been positive and users said they appreciate the opportunity to refine the dataset to display Yellow Card data which they are particularly interested in.
Supporting biological standards and control
Each year in the autumn, NIBSC presents proposals for the establishment of new or replacement WHO International Reference Materials that will be developed and manufactured by NIBSC to the World Health Organisation (WHO) Expert Committee on Biological Standardisation (ECBS).
Of the 24 proposals presented this year, over half were for a 1st International Standard or Panel including the proposal to make a gene therapy standard.
This year NIBSC and the National Institute of Food and Drug Safety Evaluation (NIFDS) from the Republic of Korea signed a memorandum of understanding (MoU) with the aim of promoting biological standardisation.
This could be achieved through international collaborative studies, the pursuit of areas of mutual benefit, from access to, optimization of processing and transport of material, to building regulatory competence by exchange of scientific experts and joint workshops.
The alliance also helps to enhance the global reach for both sides and highlights the role NIBSC plays in assuring the quality of biological medicines around the world.
Saving the Taxpayer money
Earlier this year the Energy Manager at NIBSC was crowned Energy Institutes Energy Manager of the Year at a glittering ceremony in London. This award recognises outstanding individual performance in energy management from implementing strategies and specifying technology, to engaging employees and other stakeholders.
Single handedly, though with the support of senior managers and colleagues, Jude Hughes established a comprehensive in-house Environmental Management System from scratch at NIBSC, while consistently promoting the development of a green culture within the organisation. Judes hard work and innovative approaches has resulted in an estimated 1 million saving over the past five years, including a reduction in NIBSCs electricity and gas usage of 14% and 20% respectively.
Continually improving our innovative Yellow Card App
In an innovative move to mix digital with healthcare services for an improved user experience when reporting suspected problems with medicines, we worked with the Innovative Medicines Initiative WEB-RADR to develop a free Yellow Card app which launched in 2015. The app now has more than 3000 users. Ba