Who makes the decisions?

There are three main groups within the MHRA involved in regulatory decisions:

 

• Staff – the Agency’s professional staff make many decisions about the safety and performance of medicines and medical devices on a day-to-day basis, and about the quality of manufacturing and distribution. An Executive Board of senior staff oversees the work of the Agency and takes ultimate responsibility for the decisions made.
  
  
  
• Advisory Committees – groups of independent experts and lay representatives who advise on whether medicines and devices work and are acceptably safe, based on an evaluation of all relevant evidence, including that from the Agency. These groups include the Commission on Human Medicines, its Expert Advisory Groups, and the Committee on the Safety of Devices.
  
  
  
• The Agency Board – which is made up largely of external members, acts in a supervisory and advisory capacity and has a particular role in assuring the quality of decision-making.
  
  
  

In law, decisions by the Agency are decisions of the Secretary of State for Health who is accountable to Parliament. Ministers also make decisions on matters of significant public concern from time to time, advised by the Agency or its expert committees.

There are other organisations and bodies outside MHRA which are also concerned with safety, quality and/or performance, principally in that:

• Organisations called Notified Bodies carry out a compliance assessment before manufacturers can place certain medical devices1 on the market. Notified Bodies in the UK are designated and audited by MHRA.
  
  
  
• Many decisions made by or within other Member States of the European Union and by the European Medicines Agency2 must be respected or taken into account within the UK, just as decisions of MHRA can have an impact on other Member States. Experiences of problems are also shared in both directions.
  
  
  
• Clinical trials of products are subject to the approval of ethics committees, complementing the role of MHRA, which is principally concerned with the scientific evidence.
  
  
  

We do not and should not have direct influence over ethics committees or European partners but recognise that their decision-making often follows similar principles; if we have cause for concern about decisions taken by others, we make that known through appropriate channels.

It is for doctors and other healthcare professionals to determine the suitability of particular medicines or medical devices for individual patients under their care, weighing benefits against risks and subject to guidance from the NHS and NICE.

Patients and the public will often have their own views about the suitability of particular medicines or medical devices. They are usually free to decide for themselves whether to use the products or not, supported by reliable information about risks and benefits.

We encourage both patients and healthcare professionals to report adverse events, through the Yellow Card scheme for medicines or Adverse Incident report forms for devices. These reports are important to the Agency, which analyses them alongside other new sources of information to determine whether action is needed.

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1.  This applies to medium and high risk devices, including active implantable devices and certain in-vitro diagnostic devices, and devices supplied sterile or which have a measuring function. Assessment may include quality assurance, examination of the design or product testing. For other lower risk devices, manufacturers make declarations that their devices meet statutory requirements for CE-marking.

2.   The EMEA must authorise medicinal products derived from biotechnology and other high-technology processes, and medicines for certain diseases. The evaluation of evidence is delegated to regulatory agencies of Member States, including MHRA, but the concerns of all Member States are taken into account.

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