When a new medicine becomes available in the UK, it has usually gone through many years of laboratory research, clinical trials and careful regulatory review. One of the key organisations involved in this process is the Medicines and Healthcare products Regulatory Agency, commonly known as the MHRA.
The MHRA is the UK’s medicines and medical devices regulator. It works to protect public health by ensuring that medicines and medical devices meet appropriate standards of safety, quality and effectiveness before they are made available to patients. The MHRA also continues to monitor medicines after they have been approved, helping to identify any new safety concerns that emerge over time.
What does the MHRA do?
The MHRA is responsible for evaluating medicines before they can be marketed in the UK.
When a pharmaceutical company wants to make a medicine available to patients in the UK, it must apply for a marketing authorisation. The MHRA reviews the scientific evidence supporting the medicine, including data from laboratory research and clinical trials, to determine whether its benefits outweigh its risks.
If the evidence shows that the medicine meets the required standards of safety, quality and effectiveness, the MHRA may grant a UK marketing authorisation.
This process is particularly important for innovative medicines, including treatments for cancer, rare diseases, diabetes, autoimmune conditions, viral infections and advanced therapies such as gene and cell therapies.
The MHRA also works closely with other trusted international regulators, considering evidence from organisations such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and other regulatory authorities when appropriate.
Safety monitoring does not stop after approval
A medicine’s journey does not end once it is approved. As medicines are used by larger and more diverse groups of patients in routine healthcare, additional information about their safety may become available.
For this reason, the MHRA continues to monitor medicines throughout their lifecycle through a process known as pharmacovigilance.
Pharmacovigilance involves collecting and analysing reports of suspected side effects, reviewing new safety data, updating prescribing information and taking action when necessary to protect patients. These actions may include adding new safety warnings, changing recommendations on how a medicine should be used, restricting its use or, in rare cases, suspending or withdrawing a medicine from the UK market.
What does the MHRA not do?
Although the MHRA plays a central role in regulating medicines, it is not responsible for every aspect of healthcare.
For example, the MHRA does not decide how much medicines cost or whether they will be funded by the NHS. These decisions are made separately by organisations such as the National Institute for Health and Care Excellence (NICE) in England, the Scottish Medicines Consortium (SMC) in Scotland, and equivalent bodies in Wales and Northern Ireland.
The MHRA also does not provide personal medical advice or write clinical treatment guidelines for healthcare professionals.
How are clinical trials authorised in the UK?
Before a clinical trial of a medicine can begin in the UK, the sponsor must apply for authorisation from the MHRA.
The MHRA reviews the scientific aspects of the proposed study, while an independent Research Ethics Committee reviews the ethical aspects, including participant safety, informed consent and patient protection.
Only after receiving the necessary approvals can the trial begin.
Clinical trials are carried out in phases. Early phase 1 studies primarily assess safety and dosing, phase 2 studies explore safety and early signs of effectiveness, and larger phase 3 studies compare new treatments with existing standards of care. The evidence generated during these studies may later support an application for marketing authorisation.
Why patients should know about the MHRA
Patients, carers and healthcare professionals all play an important role in medicine safety.
Anyone can report suspected side effects through the MHRA’s Yellow Card Scheme. These reports help the MHRA identify potential safety issues that may not have been apparent during clinical trials and contribute to ongoing monitoring of medicines used across the UK.
The MHRA also provides publicly available information about medicines, safety updates and regulatory decisions to help patients and healthcare professionals make informed choices.
While the MHRA regulates clinical trials, it does not recruit volunteers to participate in research studies. This is where patient communities such as the British Research Panel play an important role. We help people learn about clinical research, understand what participation involves, and connect with studies that may be suitable for them.
Source
The information presented in this article is based on guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA).