Before they reach the patients who need them, and to ensure their continued safety once in wider use, all medicines, vaccines and medical devices must be strictly regulated by authorities.
The Medicines and Healthcare Products Regulatory Agency (MHRA) exists to make sure that medicines, vaccines and medical devices work properly and meet the standards of safety, quality and efficacy. It assesses all new medicines before they can be sold in the UK and continues to monitor the safety of medicines once licensed.
When the MHRA become aware of a potential issue with a medicine or medical device, they will take action to deal with it – this may include alerting healthcare professionals or in some cases withdrawing a medicine from the market.
They also work closely with the European regulator, the European Medicines Agency (EMA), which has a similar role to the MHRA but is responsible for the scientific evaluation, supervision and safety monitoring of human and veterinary medicines in the European Union (EU).
Pharmaceutical companies can submit a single application to the EMA for marketing authorisation in all EU Member States, as well as Iceland, Liechtenstein and Norway.
This is compulsory for some types of medicines, such as for the treatment of HIV/AIDS, cancer, diabetes and viral diseases; advanced-therapy medicines, such as gene-therapy, somatic cell-therapy or tissue-engineered medicines; and medicines used for rare diseases.
Medicines that do not fall within the categories would normally be approved by national agencies like the MHRA.