EU- FAQs_EMA_updated 15Jun2020

We have the pleasure to announce that Pharmya has received CIR accreditation for a three-year period (2020, 2021 and 2022) from the French Ministry of Higher Education and Research. The French R&D tax credit initiative (‘Crédit d’Impôt Recherche’, CIR) gives…

EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines

EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation.

Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation

Information on ongoing COVID-19 clinical trials in the European Economic Area (EEA)

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.

The ANSM was informed of the position of the scientific committee of the international Solidarity clinical trial in collaboration with the WHO on the suspension of the inclusions of new patients who had to be treated with hydroxychloroquine

On 19 May 2020, the Commission published an amendment to Commission Implementing Regulation (EU) 920/2013.