Conditional Marketing Authorisations (CMAs) were introduced in Great Britain as a scheme by the MHRA in January 2021. The CMAs can be granted for new medicinal products in GB whose benefits outweigh the potential risks of the new medicinal product. The scheme functions similarly to the Conditional Marketing Authorisation scheme which had already been introduced by the European Medicines Agency (EMA) for the European Economic Area (EEA).
The GB scheme follows the same criteria as of that introduced by the EMA, namely the medicinal product receiving a CMA must fulfil an unmet medical need. As the medicinal product offers large medicinal and therapeutic benefits for patients, the comprehensive clinical data normally required for a standard Marketing Authorisation (MA) may be lessened. The CMA is only granted if it is judged that comprehensive clinical data will become available shortly in the future.
CMAs are valid for one year and can be renewed annually. Legibility of a product for a CMA in GB will ultimately be the decision of the MHRA, however the EMA CMA register may be reviewed for evidence.
One of the most recent medicines granted a CMA is Paxlovid, a treatment for COVID-19 which is taken early upon the onset of symptoms. COVID-19 treatments are a perfect example of the use of the GB CMA scheme. There is often a lack of comprehensive clinical data owing to the virus being relatively new, and there is a high demand for effective covid treatments.
Paxlovid is an antiviral medicine that works by preventing replication of the corona virus within the body. It is a combination of 2 medicines, namely nirmatrelvir and ritonavir. Nirmatrelvir exhibits the antiviral effect which prevents virus replication. Ritonavir acts as a stabiliser, allowing the antiviral effects to exist for longer in the body.
Paxlovid is available on prescription for patients in the highest risk groups. Treatment of Paxlovid must be started within 5 days of the onset of covid symptoms. The treatment helps to prevent severe illness developing which is more occurs more often in patients in the highest risk groups.
For more information, please refer to the articles linked below –
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Regulatory approval of Paxlovid
https://www.gov.uk/government/publications/regulatory-approval-of-paxlovid
About Paxlovid