MHRA review looks at medical device
According to the findings of a Triennial Review of the Medicines and Healthcare products Regulatory Agency (MHRA), the UK is well-placed to steer a global drive to improve public health
The review of the MHRA was published to ensure it remains fit for purpose.
The Triennial Review also recommended that the MHRA reviewed its plans for income generation, continued to promote innovation and digital solutions, and increase awareness and engagement of its Yellow Card Scheme.
This scheme is an early warning system to identify potential side-effects and adverse reactions with medicines.
People can also use the scheme to report problems with medical devices as well as suspected counterfeit medicines and medical devices.
The review found that MHRA plays a critical role across each of its regulatory, science and research responsibilities and should continue to operate in its current form.
Chief executive Dr Ian Hudson, MHRA, said: “We welcome the findings of the Triennial Review
“There are some interesting challenges ahead, both domestically and globally, but the review has validated that we are well prepared to enthusiastically tackle them head on.”
The review took place between November 2014 and May 2015 and was led by a small designated team, within the Department of Health team, working under the direction of an independent sponsor and project board.
The emerging findings were also regularly scrutinised by an external challenge group chaired by a DH non-executive director.
Evidence was gathered through stakeholder interviews and workshops, meetings with sector experts, a public call for feedback and in-depth analysis of published material and in-house documents.
The publication of the Triennial Review ties into MHRA’s 2015/16 business plan and the ongoing delivery of a five year corporate strategy.
This year’s objectives for the company are:
- Working on EU negotiations and implementation relating to clinical trials, falsified medicines and medical devices
- Collaborating with the Department of Health, and partners in the health and care system, to ensure all are working towards common goals around public health, innovation and growth
- Development in science, including developing the capabilities of the National Institute for Biological Standards and Control (NIBSC)
- improving and enhancing incident and safety reporting systems, principally the Yellow Card Scheme
See the MHRA Triennial Review for more information.