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Healthcare: Medical & Regulatory Affairs

What do medical regulators do?

Although plutonium anti-fungal toothpaste may give you shiny white teeth and there’s no doubt it has a great slogan - ‘the atomic toothpaste’ - the fact that all your hair would fall out and you’d probably be dead by the weekend means it could be difficult to sell, even if Tesco have it on special offer.

Luckily for us, we have an entire regulatory system to ensure dangerous or damaging medical products do not get to market and any that do are quickly removed. This is dealt with on a national and European level.

The Medicines and Healthcare products Regulatory Agency (MHRA), which is an executive agency of the Department of Health, is the leading national body for these matters. The European Medicines Agency, meanwhile, works towards developing a harmonised level of medical standards across the European Union (N.B an executive agency performs a function of government, but has its own budget and managerial responsibilities).

What does medical regulation involve?

The regulatory system for medicines and medical equipment in the UK has developed over the last century. Unfortunately, this growth has stemmed from a series of accidents and mistakes that have had some really damaging effects.

The most prominent mistake of the past few decades was Thalidomide: a drug recommended to pregnant women in the late 1950s as a sedative, which resulted in debilitating birth defects. Therefore, as you can see, careers in this field are incredibly important and any mistakes can be extremely costly.

If you pursue a career in this area, you are likely to be working as a medical researcher; however, you will also have the possibility of developing a career as an inspector or within a corporate services department, such as compliance management, information management, accounts and human resources.

This regulatory work covers all medicines and medical equipment, from condoms and wheelchairs, to all of those scary gizmos that dentists stick in your mouth. Data capture and information management are hugely important to this area of work and a large number of professionals who work in medical and regulatory affairs have a strong academic background in scientific or mathematical subjects.

How do I get into medical regulation?

Careers in this area of healthcare come with a lot of responsibility. For the most part, it’s likely that you will be working as a civil servant. However, pharmaceutical companies also employ research scientists and engineers to ensure that their medical products and equipment are safe before they are tested again by the MHRA.

Medical and regulatory affairs can be divided up into the following areas:

  • Inspection and enforcement
  • Licensing
  • Risk management
  • Testing
  • Research.

It’s really important that new medicines and medical devices are meticulously checked before they are made available to the public. Sometimes, however, products slip through the net and are sold before they have been cleared as being safe.

If people are selling items that have not been approved, they must be removed from sale and the culprits involved in the distribution and production of these items may be prosecuted. For instance, if a company just started selling ‘atomic toothpaste’, someone would be employed to hold the culpable people accountable!

People involved in the licensing side of things approve new additions to existing medicines or different proposed uses for the same medication. This is done to make sure that the changes have no adverse effects on people.

Another group of people are employed to assess the risks associated with medicines or medical equipment. These guys are the ones that make sure that medicines carry appropriate warnings and instructions for use. As time goes on and new research findings become available, the risks and instructions are altered, changed and reviewed to make sure that the general public is kept as safe as possible.

Research is a major part of this field and all newly proposed medicines and devices that companies would like to sell in the UK must be tested, verified and approved by research scientists. Research is conducted by the Medicines and Healthcare products Regulatory Agency, the European Medicines Agency and pharmaceutical companies themselves.

If you’re interested in this side of healthcare, check out the occupational profile of a regulatory affairs officer to find out more!

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