EMA Pre-authorisation guidance (Human Regulatory)

July 19, 2022

Person typing on laptop.
Small flags for the US and EU standing next to each other on a glass desk.

June 2, 2022

EMA appoints Chief Medical Officer

June 1, 2022 Steffen Thirstrup has been appointed as Chief Medical Officer of EMA. In this role, he will provide scientific leadership across EMA and its scientific committees to reinforce the...

European Flag stars over a wavy blue background.

August 3, 2022

EMA: List of centrally authorised products requiring a notification of a change for update of annexes

August 2022 EMA Regulatory and Procedural Guideline Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing...

Several COVID-19 vaccine vials lined up on a table.

June 24, 2022

EMA Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus

8 June 2022 EMA/175959/2021 Rev.2 Human Medicines Division Regulatory and procedural requirements Introduction In order to ensure the continued effectiveness of authorised COVID-19 vaccines, it may...