MHRA (Medicines and Healthcare Products Regulatory Agency UK)

(Medicines Regulatory Agency for the UK)

 

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgements to ensure that the benefits justify any risks. 

 

The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC), (external link)  and the Clinical Practice Research Datalink (CPRD). (external link) The MHRA is an executive agency of the Department of Health.

 

Watch the MHRA video with Ian Hudson, Chief Executive, describing the role of the organisation.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MHRA vision and values

 

Vision

 

We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

 

Values

In pursuing our vision we will strive to be:

  • innovative

  • proactive

  • impartial

  • evidence-based

  • open

 

Trustworthy

MHRA aims and objectives

 

Aims

 

MHRA aims are:

 

  • Protecting public health through regulation, with acceptable benefit-risk profiles for medicines and devices.

  • Promoting public health by helping people who use these products to understand their risks and benefits.

 

Improving public health by encouraging and facilitating developments in products that will benefit people.

 

Objectives

 

MHRA strategic objectives are to:

  • safeguard public health through our primary role in ensuring that the products we regulate meet required standards, that they work and are acceptably safe

  • carry out our communication role through the provision of accurate, timely and authoritative information to healthcare professionals, patients and the public

  • support research, ensuring through the application of Better Regulation principles that regulation does not stifle innovation

  • influence the shape of the future regulatory framework through use of our effective European and International relationships

 

Run an organisation with a skilled and equipped workforce that is fit for the future.

 

 

These are achieved through:

 

  • authorising medicines before they can be marketed, taking both their safety and effectiveness into account

  • ensuring clinical trials meet robust standards and safeguard patient’s interests

  • inspecting the quality of medicines as manufactured and distributed

  • overseeing UK Notified Bodies that audit medical device manufacturers

  • encouraging everyone to report suspected problems with both medicines and devices and then investigating these reports

 

Investigating, and prosecuting where necessary, cases of non-compliance including advertising claims.

 

Source: MHRA 2015

 

 

Thalidomide Connection to MHRA

 

It is important to remember that the MHRA a was set-up as a result of the thalidomide tragedy.

 

The British government had acknowledged that thalidomide was not regulated properly in the UK along with over medicines that caused side-effects (not necessary birth defects)

 

 

Thalidomide UK meets with the MHRA regularly (2-3 times a year) regarding the regulatory of the drug thalidomide and its use today.

 

Thalidomide is used to treat multiple myeloma and is licensed in the UK. The drug is also used with other diseases/illnesses such as blood cancers bechet syndrome and Crohn's disease.

 

Thalidomide UK does not support the use of the drug, however we do support regulatory programs.