Conditional marketing authorisation (CMA) means the accelerated act of allowing the approval of a vaccine that addresses an unmet medical need with a positive benefit – risk balance. CMAs are based on less comprehensive pharmaceutical data than a normal procedure. They are necessary to respond rapidly to public health threats, with health, social and economic impact. Specific requirements for conditional marketing authorisation need to be met within a defined timeframe. It is important to note that the safety requirements for a novel vaccine will not be lowered and remain the same as for any other vaccine in the EU. Furthermore, the submitted data need to be sufficiently complete in order to show the safety, quality and effectiveness of the vaccine. The benefits need to outweigh any risks. Moreover, even when a CMA has been granted, ongoing or new studies will still be necessary. The CMAs do not remain indefinitely, but are valid for one year only and can annually be renewed. The marketing authorisation may be transformed into a standard one as soon as comprehensive data have been obtained.
CMA applies to 31 countries served by the European Medicines Agency (EMA)
The EMA (European Medicines Agency) promotes and protects human and animal health. This agency serves the 28 EU member states, Iceland, Liechtenstein as well as Norway and is a decentralized agency of the EU. The U.S. equivalent to the EMA is called Food and Drug Administration (FDA).
Normally, the EMA finishes the scientific review process within 210 days. However, in the case of the COVID-19 vaccine, the agency will proceed more rapidly as CMA may be granted in emergency situations in response to threats to the public health.
The European Commission will grant the needed marketing authorisation for the whole EU as soon as the scientific evidence affirms a positive benefit-risk assessment. The thorough assessment will be carried out by the EMA.
Read our article on the immune system to learn more.
This week, you can tune in to another IATE goes Audio feature: click below to listen to ‘Conditional marketing authorisation’ explained in English.
EMA. 2020. Conditional Marketing Authorisation. [ONLINE] Available at: https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-mrna-vaccine-bnt162b2. [Accessed 10 December 2020].
Euractiv. 2020. Conditional Marketing Authorisation. [ONLINE] Available at: https://www.euractiv.com/section/coronavirus/news/conditional-authorisation-most-likely-for-covid-19-vaccine-ema-says/. [Accessed 10 December 2020].
EMA. 2020. Glossary. [ONLINE] Available at: https://www.ema.europa.eu/en/glossary/conditional-marketing-authorisation. [Accessed 10 December 2020].
EMA. 2020. EMA receives application. [ONLINE] Available at: https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-mrna-vaccine-bnt162b2. [Accessed 10 December 2020].
EMA. 2020. Human regulatory. [ONLINE] Available at: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/conditional-marketing-authorisation. [Accessed 10 December 2020].
Written by Victoria Milhan