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.
The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities.
This guidance provides information on how the FDA defines the types of changes to approved risk evaluation and mitigation strategies (REMS), how application holders should submit changes to an approved REMS, and how the FDA will process submissions from application…
The EMA publishes an updated version of the Designated Medical Events list
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting.
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