Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.” The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations. However, it remains to be seen whether in practice the TEMA process will provide a faster procedure than existing routes for early and expedited approval of medicinal products, such as conditional marketing authorizations (“CMAs”) or Member State procedures for temporary approval.
Reason to Introduce the TEMA
The EU took a coordinated approach to approval and procurement of vaccines during the COVID-19 pandemic. In the EU, COVID-19 vaccines were approved using the CMA procedure combined with a rolling expedited review. According to the European Medicines Agency (“EMA”), CMAs were the “the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.” Vaccines approved with a CMA included Comirnaty, Nuvaxovid and Spikevax (amongst others).
However, the approval of COVID-19 vaccines in the EU was slower than in other jurisdictions. For example, the UK MHRA granted Comirnaty a temporary authorization on December 2, 2020. The US FDA gave the vaccine an Emergency Use Authorization on December 11, 2020. Whereas, the Commission did not grant a CMA for the vaccine until December 21, 2020.Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations