MEDICINE LICENSING PROCESS IN UK (MHRA)
- A licence, also referred to as a marketing authorization, from the MHRA is required before any medicine can be used to treat people in the UK.
- To begin the process, companies and/or researchers must apply to the MHRA for permission to test drugs through clinical trials, if these trials are to be conducted in the UK.
- In order to receive permission to run a trial, they must first satisfy the MHRA that they have met strict safety criteria. All the test results from these trials on how well the medicine works and its side effects, plus details of what the medicine contains, how it works in the body, and whoit is meant to treat, are then sent to the MHRA for detailed assessment.
- The assessment team is made up of experts from different relevant specialties, each of whom has undergone additional training in medicines assessment. The length of the assessment process depends on the type of medicine as well as the quality of the initial information supplied by the manufacturer, how much further detail is required, and how soon queries can be resolved.
- In the past, all this information used to be supplied in paper format; now it is supplied electronically, to minimise procedural delays. The MHRA also has to comply with strict timeframes and performance targets for the licensing of medicines.
- Once the MHRA is satisfied that the medicine works as it should, and that it is acceptably safe, it is given a marketing authorisation or product licence.
- The pharmaceutical company and any wholesalers must also be able to satisfy the MHRA that the manufacture, distribution, and supply of the medicine meet the required safety and quality standards.
- Most new types of medicine are licensed by the EMEA, to ensure that it is available to, and used
- in the same way, across all the member states of the European Union (EU). The breast cancer treatment Herceptin and the antiviral medicine Tamiflu are some examples.
- Sometimes the MHRA will be asked to take the lead on the licensing process in Europe, particularly for biological and biotechnology treatments, such as gene therapies. This is an area in which the MHRA has already developed considerable expertise.
MONITORING NEW MEDICINES AND VACCINES:-
- New chemicals and vaccines are effectively put on probation for up to two years and labelled with a black triangle to ensure prescribers are aware of the need to monitor them carefully.
- The black triangle symbol accompanies new medicines and vaccines in prescribing manuals, product information, and advertising material. It prompts healthcare professionals to report any potential side effects to the MHRA.
- This information helps to build up a broader picture of how the treatment works in the general population and enables the MHRA to act promptly, should a previously unrecognised and serious side effect come to light.
- The black triangle may also be assigned to a medicine that has already been licensed if it contains a new combination of active chemicals or if it is being used in a new way or for a different condition.
- The black triangle is not removed until the MHRA is satisfied that the medicine works safely in large numbers of people. Additionally, the MHRA also asks manufacturers to keep a close watch on side effects that may be associated with newly marketed products.