Europe – HMA/EMA statement on approval of vaccines

Development and deployment of safe and effective vaccines is seen as an essential element in the management and solution of the COVID-19 pandemic. There are no COVID-19 vaccines approved yet in the European Union, but due to the urgency posed by this health crisis, different mechanisms are in place to expedite the development of such vaccines in order to make them available as soon as possible while safeguarding the mandatory requirements of quality, safety and efficacy.

According to EU legislation (Regulation 726/2004) most COVID-19 vaccines fall under the scope of the centralised procedure since they are produced by biotechnological processes for which the centralised procedure is mandatory (as listed in Annex 1 to the Regulation). For other types of vaccines currently under development, such as those composed of whole-inactivated virus or live attenuated virus, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) network encourage marketing authorisation holders to submit their applications through the centralised procedure in order to ensure that those vaccines reach all Member States at the same time, with no unfair access in the Union. This is possible according to Article 3.2 of the above-mentioned Regulation…